GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Domestic: PA & VA    Foreign:   VA/DOD: None
Morton Salt with YPS, 50 lb. bag, ): Low-density polyethylene form fill and seal bag
Morton Salt, Inc. initiated a voluntary recall of Morton Fine Solar Salt with YPS used in animal feed due to contamination with trace amounts of foreign material .
Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By:  LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076
Marketed without an Approved NDA/ANDA:  The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims.  The product is also misbranded as it fails to bear adequate directions for its intended use.
AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, ME, MI, MO, NE, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA
Hyliderm + PS Mousse, Phytosphingosine salicyloyl 0.05%, Net Contents:  6.8 FL OZ (200 mL).  NDC: 13744-127-01
Microbial contamination of product with Penicillium citrinum and Penicillium mallochii.
Product Item Number FSHYLPS3068; Lot 160301B (Exp Date 4/11/2018).   Product Item Number FSHYLPS3068CL; Lot 170321B (Exp Date 3/18/2019)
Henry Schein, PhytoVet EFA Mousse, Phytosphingosine 0.05%, Net Contents:  6.8 FL OZ (200 mL).  Manufactured for Sogeval Laboratories, Inc., Irving, TX 75038. NDC: 11695-7200-1
Product Item Number FSHYLPS3068HS; Lots 160301A (Exp Date 4/11/2018), 170321A (Exp Date 3/18/2019)
BAYER Droncit (praziquantel), Feline Cestocide Tablets, 23mg tablets [50 count and 150 count]. Sold to veterinarians only.  Bayer HealthCare LLC, Animal Health Division Shawnee Mission, Kansas 66201, USA
2,368 bottles (2,218 50Ct bottles, 150 150Ct bottles)
Affected lot numbers may contain broken or crumbling tablets.
[50 Count] Lot AH01PX5, Product Code 8713165, Expiration JUL 2020;    [150 Count] Lot AH01R83, Product Code 08713211, Expiration JUL 2020
US Nationwide in the states of :  AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
Brivo MR355, Optima MR360    Product Usage:  The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Signa PET/MR (K163619, K142098)    Product Usage:  The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Optima MR450w 1.5T    Product Usage:  The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w 1.5T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
SIGNA Creator, SIGNA ExplorerProduct Usage:  1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by 1.5T SIGNA Creator and 1.5T SIGNA Explorer reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Optima MR450 1.5T    Product Usage:  1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the 1 .5T Brivo MR355 and I .5T Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Discovery MR750 3.0T    Product Usage:  Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Optima MR750  3.0T    Product Usage:  The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450 1.5T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant    Product  Usage:  The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Fisherman's Reserve 12/12oz Sweet Potato Cod,  Item Number: B1379
HFS 1/30 Fish-In-A-MinuteTM Crispy Style Breaded Pollock Squares 2.5 oz., Par-fried, Item Number: 23253
HFS 1/10 Crunchy Raw Breaded Alaska Pollock Squares 4 oz., Item Number: 1089097
Sea Cuisine 8/9 oz., Pan Sear Teriyaki Sesame Salmon. Item Number: SA1467
National Food Group 1/20lb Precooked Breaded Haddock Portions 4 oz., Item Number: 10800
HFS 4/4.5 Whole Grain Oven Ready Crunchy Breaded Sweet Potato Pollock Fillets 3.6 oz., Item Number: 1089870
Sysco 2/5lb Chicken Fried Pollock Strips 1-2 oz., Item Number: 10026806
Viking 2/5lb Natural Breaded Flounder 4oz. Item Number: 03194R
HFS 1/12lb Crunchy Raw Breaded Cod Squares.  Item Number: 10003217
Viking 2/5lb Beer Battered Pollock 2oz.,  Item Number: 06092R
HFS 4/5 Oven Ready Whole Grain Breaded Alaska Pollock Sticks. Item Number: 1089867
HFS 1/10lb Crunchy Raw Breaded Alaska Pollock Fillets 1.5-3.0 oz., Item Number: 1089328
FPI 1/10LB Country Style Battered Cod Portions 3.75oz,  Item Number: 02283
HLSC 12/8.5oz Mediteranean Crusted Salmon,  Item Number: S1089463
Icy Bay 1/10lb Raw Breaded Natural Cod Fillet 3.5-4.5 oz.., Item Number: 25463
Sysco 1/10lb 5 oz.  Almond Crusted Sole with Lemon and Chives. Item Number: 1049891
HFS 1/10LB Lightly Breaded Cod Tail Portions 8oz,  Item Number: 02078
HFS 1/10.35 Oven Ready Whole Grain Breaded Cod Rectangles 3.6 oz.,  Item Number: 26243
HFS 1/10 Oven Ready Whole Grain Breaded Cod Nuggets 1 oz., Item Number: 26244
Sea Cuisine 8/10.5 oz., Honey Chipotle Salmon,  Item Number: A1465
Best Choice 12/18.2oz Beer Battered Fish Fillets,  Item Number: SB1401
Icy Bay 1/10LB Oven Ready Tortilla Crusted Tilapia 4-6oz.,.  Item Number: 27481
HFS 1/10.35 lb Whole Grain Oven Ready Potato Breaded Pollock Wedges 3.6 oz,, Item Number: 53374
HFS 1/10lb Raw Breaded Natural Flounder Fillets 4 oz avg., Item Number: 1049318
HFS 1/10 Whole Grain Southern Style Oven Ready Breaded Pollock FishFries 1.25 oz.,. Item Number: 53126
HFS 10/6lb Crunchy Row Breaded Cod Rectangles 3 oz.,  Item Number: 10002800
Sysco 1/10lb Raw Breaded Atlantic Cod Squares 4oz.,.  Item Number: 31411
Viking 2/5lb Oven Ready Breaded Flounder Fillet 4oz.,  Item Number: 03195R
HFS 1/10lb Lightly Breaded Pollock Tail Portions 4 oz.,  Item Number: 06074
HFS 2/5lb Crunchy Breaded Ocean Perch Fillets 2-3 oz..,  Item Number: 05610
Gordon Food Service 2/5LB Whole Grain Breaded Alaska Pollock Nugget 1oz ., Item Number: 10026693
HFS 1/10LB Crunchy Breaded Ocean Perch Fillets 3oz,  Item Number: 05223
HFS 1/10LB Lightly Breaded Flounder Portions,  Item Number: 03074
Sea Queen 8/13.1oz Beer Battered Cod,  Item Number: B1414
HLSC 12/10oz Coconut Crusted Tilapia,  Item Number: 1089431
Sysco 1/10lb Cod Rectangle Parfried Whole Grain Breaded 3 oz., Item Number: 21312
Best Choice 12/12oz Breaded Minced Fish Sticks; Item Number: B1000
Sea Cuisine 8/9 oz Pan Sear Garlic & Herb Tilapia,  Item Number: SA1468
Sea Cuisine 12/1.9lb Pan Sear Garlic & Herb Flounder, Item Number: A1507   ,  Item Number: A1507
BURGER KING 10 X 3.49 LB SEASONED FRESH ALASKA POLLOCK PORTIONS, 3.10 OZ. CANADA PRODUCED  Item Number: 33312
Sea Cuisine 8/9 oz., Pan Sear Garlic & Herb Tilapia. Item Number: SA1468
FPI 1/10.35 Crunchy Lites Raw Breaded Alaska Pollock Portions 3.6 oz.., Item Number: 06333
Icy Bay 1/10lb Raw Breaded Natural Cod Fillet 2.5-3.5 oz.., Item Number: 25461
HFS 4/5 Oven Ready Whole Grain Breaded Pollock Nuggets 1 oz.,  Item Number: 1089863
HFS 1/10.35 Oven Ready Whole Grain Breaded Pollock Rectangles 3.6 oz., Item Number: 26373
Big Y 12/25oz Breaded Minced Fish Sticks,  Item Number: SB1202
Parade 12/24oz  and 12/12oz., Breaded Minced Fish Sticks,  Item Number: 6412, 6414
Viking 1/30lb Precooked Breaded Flounder Fillets. Item Number: 19902800
HFS 1/10 Oven Ready Whole Grain Breaded Alaska Pollock Rectangles 3.0 oz.,, Item Number: 26245
Super A 12/25oz Breaded Minced Fish Sticks,  Item Number: B1213
Big Y 12/25oz Breaded Minced Fish Sticks,  Item Number: B1202
American Pride 1/10lb Oven Ready Crunchy Breaded Pollock Portions, Item Number: 78122
HFS 1/20 lb. Whole Grain Oven Ready Potato Breaded Alaska Pollock FishFries 1.3 oz,, Item Number: 53448
Sea Cuisine 8/10.5 oz., Honey Chipotle Salmon,  Item Number: SA1465
Sea Queen 8/24oz Fish Sticks,  Item Number: B1179
Best Choice 12/12oz Breaded Minced Fish Sticks,  Item Number: B1000
Viking 12/1LB Precooked Cod Fillet 4oz,  Item Number: 02620
HFS 1/10LB Lightly Breaded Cod Tail Portions 5oz,  Item Number: 02075
FPI 1/10lb PAN-SEAR Chili Lime Tilapia Fillets, Item Number: 1059540
HFS 1/20 Oven Ready Crunchy Sweet Potato Alaska Pollock Nuggets 1 oz., Item Number: 53978
HFS 1/10 Precooked Ovenready Breaded Formed Fish Shapes 0.875 oz., Item Number: 1005172
HFS 1/10 Lightly Breaded Cod Tail Portions,  Item Number: 02074
HFS 1/10lb Oven Ready Krispy Krunchy Breaded Pollock Nuggets 0.85 oz., Item Number: 06791
HFS 1/20 lb Whole Grain Oven Ready Corn Meal Breaded Alaska Pollock FishFries 1.25 oz., Item Number: 53989
HFS 1/10lb Oven Ready Krispy Krunchy Breaded Pollock Nuggets 0.85 oz.., Item Number: 06790
HFS 1/20 lb Whole Grain Oven Ready Potato Breaded Alaska Pollock Nuggets .875 oz., Item Number: 53458
HFS 1/10.5 lb Oven Ready Krispy Krunchy Breaded Pollock Rectangles 3 oz., Item Number: 06793
HFS 2/5 Oven Ready Whole Grain Breaded Seabob Shrimp Popper., Item Number: 26242
HLSC 1/10lb Coconut Crusted Tilapia with Mango & Papaya,  Item Number: 1089531
Best Choice 12/24oz Breaded Minced Fish Sticks; Item Number: B1114
WF365 12/12oz Beer Battered Cod Fillets ,  Item Number: B1356
Sea Queen 9/15oz Encrusted Tilapia Fillets,  Item Number: B1290
HFS 1/20lb Whole Grain Nacho Encrusted Alaska Pollock Sticks 1oz., Item Number: 38118
American Pride 1/10lb Fully Cooked Gourmet Breaded Pollock Squares 2 oz.,, Item Number: 23200
HFS 1/10lb Breaded Haddock Tail Portions 5oz ,  Item Number: 01075
Sea Cuisine 1/10lb Raw Breaded Crispy Style Fish Portions 4 oz., Item Number 10026645, 10026646
Icy Bay 1/10lb Beer Battered Natural Cod Nugget 1-2 oz  , Item Number: 23845
HFS 1/10 Oven Ready Whole Grain Breaded Pollock Nuggets 1.0 oz.,, Item Number: 26530
Big Y 12/25oz Breaded Minced Fish Sticks; Item Number: B1202, SB1202
Icy Bay 1/10lb Beer Battered Natural Cod 3.5-4.5 oz., Item Number: 23895
HFS 1/10 Fish-In-A-MinuteTM Crispy Style Breaded Alaska Pollock Squares 2.5 oz Par-fried, Item Number: 23251
Sea Cuisine 12/9oz Pan Sear Teriyaki Salmon,  Item Number: A1503
HFS 1/10 LB Raw Breaded Crispy Style Fish Portions 4 oz., Item Number: 10022627
Safeway 12/12oz Precooked Sweet Potato Cod Portion 6oz., Item Number: 51261
1/10.125 Reduced Fat Oven Ready Breaded Salmon Cakes 3 oz., Item Number: 69147
HFS 1/40 Crunchy Breaded Ocean Perch Fillet 2-3oz WIP. Item Number: 19905610
Icelandic 6/4lb Guinness Battered Cod Fillets 4 oz., Item Number: 10026799
HFS 10/6lb Crunchy Breaded Alaska Pollock Squares 4 oz., Item Number: 10003474
HFS 1/10 Oven Ready Whole Grain Breaded Fish Sea Wonders, Item Number: 26533
HFS 1/10 Crunchy Raw Breaded Alaska Pollock Squares 4 oz., Item Number: 10022628
Safeway 1/30 Oven Ready Sweet Potato Cod Fillet 6 oz.,. Item Number: 51260
Natural Sea 12/8oz Premium Cod Sticks with Multigrain Breading 0.8oz. and 2oz.,  Item Number: 6334, 6335
Icelandic 1/10lb Beer Battered Cod Portions, Item Number: 1029719
HFS 1/10lb Crunchy Breaded Cod Square 4 oz., Item Number: 10020662
IGA 12/12oz Breaded Minced Fish Sticks,  Item Number: 9590
HFS 1/10lb Oven Ready Whole Grain Breaded Pollock Sticks 1.0 oz,  Item Number: 26240
HFS 1/10lb Crunchy Breaded Ocean Perch Fillets 2-3 oz.,  Item Number: 05456
SCHWAN 8/2 LB PRECOOKED BREADED COD NUGGET, 0.5 OZ. CANADA PRODUCED. Item Number: 51154
HFS 1/10.35 Oven Ready Whole Grain Breaded Alaska Pollock Fillet Portions 3.6 oz., Item Number: 1089271
American pride 1/10lb Oven Ready Breaded Pollock Portions 4 oz.., Item Number: 7372
HLSC 12/10oz Summer Herb Crusted Cod Item Number:    1029449
Viking 1/30lb Precooked Breaded Haddock Fillets. Item Number: 19701620
Quorn 12/7.055oz Garlic & Herb Crusted Myco-Protein Cutlet 3.50oz.,  Item Number: A00115
Sea Cuisine 20/10.75oz Honey Chipotle Crusted Salmon - Foam Tray.  Item Number: A1344
Sysco 2/5lb  Chicken Fried Shrimp 18-24 ct., Item Number: 10026807
Price Chopper 12/12oz Breaded Minced Fish Sticks,  Item Number: B1030
HFS 1/10lb Oven Ready Breaded Pollock Rectangles 4 oz., Item Number: 10022117
Sea Queen 12/13.1oz  6 boxes each of Potato Crusted Cod & 6 Boxes of Beer Battered Cod,  Item Number: B1310
HFS 10/6lb Breaded Crispy Style Cod Fish Portions  Item Number: 10003220
HFS 1/20lb Whole Grain Oven Ready Corn Meal Breaded Alaska Pollock FishFries 1.25 oz.,  Item Number: S53989
HLSC 1/10lb Honey Chipotle Salmon,  Item Number: A1222
Schwan 12/1.25 lb Haddock Sticks. Item Number: 52154
HFS 1/10lb Crunchy Breaded Cod Rectangle 3 oz., Item Number: 1029504
Icy Bay 1/10lb Beer Battered Natural Cod 2-3 oz., Item Number: 23892
HFS 1/10lb Breaded Haddock Tail Portions 4oz ,  Item Number: 01074
FPI 1/10 PAN-SEAR Chili Lime Tilapia Fillets. Item Number: 1059540
Sea Cuisine 8/9 oz., Pan Sear Garlic & Herb Tilapia,  Item Number: A1468
Shop Rite 12/25oz Breaded Minced Fish Sticks,  Item Number: 9517
Icy Bay 1/10 LB Oven Ready Southern Style Breaded Tilapia 4-6oz.,.  Item Number: 27484
American Pride 1/10lb Oven Ready Crunchy Breaded Pollock Portions, Item Number: 78142
Kid Fresh 8/7.4oz Fun-tastic Fish Sticks,  Item Number: B1412
Sea Cuisine 8/9 oz Pan Sear Garlic & Herb Tilapia.  Item Number: A1468
1/25LB Fish-In-A-MinuteTM Crispy Style Breaded Pollock Rectangles 2 oz. Par-Fried., Item Number: 78901
HLSC 10LB Uppercrust Honey Chipotle Salmon 5.71oz.,  Item Number: A1222
HFS 1/10LB Crunchy Raw Breaded Alaska Pollock Squares 4 oz.., Item Number: 1029505
Sea Cuisine 1/10lb Pan Sear Garlic & Herb Tilapia Fillets,  Item Number: 1971468
Trader Joe's 24/16oz Reduced Fat Precooked Crunchy Breaded Mini Pollock Sticks .67 oz.,  Item Number: 40503
Viking 12/1LB Precooked Breaded Haddock Fillets  (PUFI),  Item Number: 01620
Southern Home 12/24oz Breaded Minced Fish Sticks,  Item Number: B1133
HFS 1/10.35lb Oven Ready Krispy Krunchy Breaded Pollock Rectangles 3.6 oz., Item Number: 06446
HFS 1/20lb Whole Grain Nacho Encrusted Alaska Pollock Sticks 1oz.,  Item Number: S38118
Kid Fresh 8/7.4oz Fish Sticks 0.53oz..,  Item Number: B1412
HFS 1/20 lb Whole Grain Oven Ready Potato Breaded Alaska Pollock Wedges 3.6 oz,,. Item Number: 53228
Sea Cuisine 8/9 oz Pan Sear Teriyaki Sesame Salmon.  Item Number: A1467
Viking 12/1lb Precooked Breaded Cod Fillets 4 oz., Item Number 02620
Fisherman's Reserve 12/1lb Breaded Haddock Fillets,  Item Number: B1378
Viking 2/5lb Precooked Whiting Fillet,  Item Number: 07094R
HFS 1/10lb Lightly Breaded Pollock Tail Portions 5 oz.,  Item Number: 06075
Sysco 1/10LB Portico Prime Premium Cornmeal Pangasius 1-2oz, Item Number: 10026363
HFS 1/10 Oven Ready Whole Grain Breaded Pollock Sticks 1 OZ.., Item Number: 26240
Sea Cuisine 8/9 oz Pan Sear Teriyaki Sesame Salmon,  Item Number: A1467
Sea Cuisine 8/10.5 oz Honey Chipotle Salmon.  Item Number: A1465
Nestle 1/30lb 147.42 gram Pollock Formed Breaded Portions Parfried.  Item Number: 1089838
HFS 1/10.35 lb Whole Grain Oven Ready Potato Breaded Pollock Wedges 3.6 oz,, Item Number: 53364
HFS 4/4.5 Oven Ready Whole Grain Breaded Pollock Rectangles. Item Number: 1089869
Icelandic 1/10LB Guinness Beer Battered Shrimp 26-31 ct., Item Number: 10026737
Icelandic 1/10LB Guinness Beer Battered Cod Fillets 4oz., Item Number: 10026732
Icy Bay 1/10lb Raw Breaded Natural Flounder Portions.  Item Number: 26624
Whole Foods 12/12oz Oven Ready Breaded Calamari Rings,  Item Number: B1322
Fisherman's Reserve 12/1lb Beer Battered Cod Fillets,  Item Number: B1376
HFS 1/10.35 Oven Ready Krispy Krunchy Breaded Alaska Pollock Fillets 3.6 oz., Item Number: 06456
Icelandic 1/10LB Guinness Beer Battered Cod Fillets 2oz., Item Number: 10026731
HFS 10/6lb Raw Breaded Haddock Portions 4 oz..,Item Number: 10003370
Best Choice 12/24oz Breaded Minced Fish Sticks,  Item Number: B1114
Gordon Food Service 2/5LB Whole Grain Breaded Cod Stick 1oz ., Item Number: 10026697
Icelandic 6/4LB Guinness Beer Battered Cod Tenders 1-2oz., Item Number: 10026798
Sea Cuisine 12/10 oz., Pub Classic Beer Battered Cod,  Item Number: A1319
HFS 1/10 Oven Crispy Breaded Minced Alaska Pollock Portions 4 oz.., Item Number: 53474
Sea Cuisine 8/9 oz Pan Sear Teriyaki Sesame Salmon,  Item Number: SA1467
FPI 1/10 Crunchy Lites Raw Breaded Alaska Pollock Nuggets 0.85 oz.., Item Number: 06230
HFS 1/10 Oven Ready Breaded Calamari Strips 0.50 oz. avg.  Item Number: 1081394
HFS 10/6lb Breaded Crispy Style Cod Fish Portions 4 oz., Item Number 10003220
Sea Cuisine 1/10lb Herb Crusted Cod,  Item Number: A1405
FPI 1/10 PAN-SEAR Roasted Garlic & Herb Tilapia Fillets. Item Number: 1059340
A&W 1/10LB Raw Breaded Fish Portions, Item Number: 10025937
Sea Cuisine 8/10.5 oz., Honey Chipotle Salmon. Item Number: SA1465
Gordon Food Service 1/10LB Whole Grain Breaded Pollock 3.6oz , Item Number: 10026691
HFS 4/5 Oven Ready Whole Grain Breaded Pollock Sea Wonders. Item Number: 1089865
FPI 1/10 4 oz Southern Style Oven Ready Striped Pangasius Fritter. Item Number: 1079340
FPI 1/10 UpperCrust Natural Cut Fillets Coconut Crusted Tilapia with Mango & Papaya., Item Number: 1089521
HLSC 12/10oz Potato Crusted Cod,  Item Number: S1029440
HFS 1/10lb Lightly Breaded Pollock Portions 8 oz., Item Number: 06078
HFS 6/3LB Golden Crunchy Fish Sticks, Item Number: 10022898
HFS 1/10.35 lb Oven Ready Southern Cornmeal Whole Grain Breaded Pollock Portions 3.6 oz.., Item Number: 06646
Sea Cuisine 20/10.75oz Honey Chipotle Salmon,  Item Number: A1344
Icelandic 1/10LB Guinness Beer Battered Cod Tenders 1-2 oz.., Item Number: 10026730
HFS 4/5lb Oven Ready Sweet Potato Crusted Alaska Pollock Nuggets 1 oz., Item Number: 1089871
Best Choice 12/18.2oz Beer Battered Fish Fillets; Item Number: SB1401
Viking 12/1lb Precooked Breaded Haddock Fillets 4 oz, Item Number 01620
US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
Truliant Tibial Trial Handle.    To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle
The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of :  Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
Worldwide Distribution - US (Nationwide) Internationally to  Japan, Hong Kong, Brunei, and Israel
ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136    Forced air dryer for medical devices
Dryer unit not heating.  Manufacturing issue causes the terminal block to overheat, char and/or burn.
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340    Forced air dryer for medical devices
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010    Forced air dryer for medical devices
D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
Worldwide - US Nationwide distribution and the countries of:  COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls    Product Usage:  IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
LeadCare II Test Kits controls out of range
Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign  countries of: Australia, New Zealand, & Japan.
Punctures in blister packaging that was detected during the packaging process.
Worldwide Distribution - US Nationwide and Puerto Rico and the following states:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico.    Distribution internationally to Argentina, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, United Arab Emirates, and United Kingdom.
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
US only - to direct accounts and online customers and sample
Bhufit Bar Vanilla Almond Cashew,  Primal Grass-Fed Whey Protein:  Net. Wt. 1.6 oz. (45G)
Bhufit Bar Superfood Chocolate Chip Brownie Batter;  Vegan Organic Pea Protein;  Net Wt. 1.6 oz. (45G)
Bhufit Bar Chocolate Tart Cherry Pistachio;  Vegan Organic Pea Protein  Net Wt. 1.6 oz. (45G)
Bhufit Bar Apple Chunk Cinnamon Nutmeg;  Vegan Organic Pea Protein  Net Wt. 1.6 oz (45G)
Bhufit Bar Peanut Butter White Chocolate;  Vegan Organic Pea Protein:  Net Wt. 1.6 oz. (45G)
Bhufit Bar Dark Chocolate Coconut Almond
Bhufit Bar Peanut Butter Chocolate Chip;  Vegan Organic Pea Protein;Net Wt. 1.6 oz. (45G)
Bhufit Bar Paleo Double Dark Chocolate Chip;  Paleo Egg White Protein:  Net Wt 1.6 oz. (45 G)
HomeChoice Automated PD system Model numbers:  5C4471, 5C4471R    Product Usage:  The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
HomeChoice Pro Automated PD system Model numbers:  5C8310, 5C8310R    Product Usage:  The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers.  If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.
Blood products, with a low platelet count, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
AZ, CA, CO, GA, IL, KY, OH, OR, TX, VA & WA
Kettle Brand Krinkle Cut Potato Chips Spicy Queso, 8.5 oz., Distributed by: Kettle Foods, Inc., Salem, OR 97301, UPC: 84114 90042
Carbohydrates on nutritional facts panel are stated as 3g/serving when the correct value is 15g/serving.
Code Dates - 21 OCT 17, 28 OCT 17, 04 NOV 17, 18 NOV 17
Product was shipped to the following states: IN, KY, OH & PA
STUTZMAN FARMS Savory Sprouted Spelt Crackers Net Wt. .30 LB. (136 g)
STUTZMAN FARMS Organic Spelt Berries 25 lb 11.4 kg 6197
Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of :  Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
Failed impurities/degradation specifications: Out of specification for a related compound C.
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam,  There was also worldwide foreign distribution, including Canada.
EMBLEM  MRI S-ICD  Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx.      Product Usage:  The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
The device can deliver an atypical amount of energy due to memory corruption inside the device.
SQ-RX 1010 Pulse Generator, Rx.     Product Usage:  The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX.      Product Usage:  The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
distributed in (Southwest and North Central) ID.
Coconut Beverage, So Delicious  brand, 1.89 liter carton.
So Delicious Coconut Beverage was recalled was recalled because it was not continuously maintained or stored at the required temperature due to a malfunction in the cooler.
Bongards Creameries Pasteurized Process American Cheese, 32 oz. package.
Bongards Creameries Pasteurized Process American Cheese was recalled because it was not continuously maintained or stored at the required temperature due to a malfunction in the cooler.
Oakdell, Medium Eggs (in shell) grade AA
Oakdell Medium Eggs (in shell) was recalled because it was not continuously maintained or stored at the required temperature due to a malfunction in the cooler.
Undeclared allergen Tree Nuts: Blackened Seasoned Pumpkin Seeds mixed up with tree nuts (almonds and cashews).
Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse.  Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
Crystallization with subpotent out of  specification assay results for chlorhexidine.
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse.  Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
Presence of Particulate Matter; stainless steel
Nationwide, US: CA, FL, GA, ID, IL, IN, TX, UT, WA, WY.  No foreign or govt/VA/military consignees.
Heart-Plus, No. 83, 120 Capsules, Dietary Supplement
Acidophilus-Plus, No. 102, 90 Capsules, Dietary Supplement,
Undeclared allergens: milk (Colostrum, Dried Yogurt, Whey).
Thymus Plus, No. 114, 90 Capsules, Dietary Supplement
Leci-thin-Plus, No. 88, 90 Capsules, Dietary Supplement
Prostate-Plus, No. 117, 90 Capsules, Dietary Supplement
Metabo-Plus, Garlic/Papaya Plus, No. 103, 90 Capsules, Dietary Supplement
Liver-Plus, No. 111 & 115, 120 Capsules, Dietary Supplement
Pancreas-Plus, No. 112, 90 Capsules, Dietary Supplement
Nationwide in Aldi retail stores from 4/13/17 to 7/27/2017
Aldi liveGfree Gluten Free Classic Soft White Hamburger Buns, 11.3 Ounces, in plastic bag
UPC code 041498 25980 8  lot number ending in 0897 (lot number found on front of package)
Distributed throughout the United States
Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033002.
Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408.
Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032500.
Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104.
Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503.
Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401.
Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03320, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033200.
Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032302.
Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101.
Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203.
Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032005.
Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005.
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Product distributed to one patient in the state of Maryland.
Lack of Sterility Assurance for compounded veterinary product.