Nationwide Distribution to OH, MI, and TX
ROSA Surgical Device 2.5.8  ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Possible break in the connector of the Force Sensor.
Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX
ROSA Surgical Device 2.5.8   ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Worldwide Distribution - US including OH and MI  Internationally to Canada, China, France, Germany, and Italy
Potential failure of the optical distance sensor due to cable disconnection.
Fosphenytoin Sodium Injection, USP,  500 mg  PE/10 mL (50 mg PE/mL.  10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only.  Packaged and Distributed by:  American Health Packaging, Columbus, Ohio 43217.  NDC:  68084-390-01
US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R    Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Worldwide Distribution to Malaysia, France, Japan, Reunion Island
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System  To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles.SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values.  The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System  To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles.SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL)  Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5   Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.
Labeling: Incorrect or Missing Package Insert.
Distribution was made nationwide.  There was government distribution and no military distribution.  Foreign distribution was made to Canada.
STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box.  Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR.  The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL  Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL  The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is intended to be used as a reservoir and fluid path for administering intravenous, subcutaneous, arterial, enteral, and epidural infusions of antibiotics, analgesics, chemotherapeutic agents, and other medications or fluids. Please note that the WalkMed 350VL pump is contraindicated for: Infusion of blood and blood products, Infusion of insulin, Infusion of critical medications whose stoppage or interruption would cause serious injury or death Use in ambulatory regimens by patients who do not possess the mental, physical, or emotional capability to operate the pump properly; or who are not under the care of a responsible individual.
CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct.  The expiration noted was not beyond initiation date of the recall. Since the product is noted as sterile, the clearance for K103340, K052925 and K991430 raises question if product was cleared with a sterility claim. Further post-market follow-up will be required to assess the safety risk of the product.
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Distribution was nationwide to medical facilities.  Foreign distribution was made to Canada and Australia.  Government and military distribution was also made.
Plum 360 Infusion System, List number 30010.
state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
Nationwide and  Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle,  Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
Domestic Only: IL, IN, KY, MI, OH, WI    No VA/DOD
Vegetable products including: Markets of Meijer SALAD ROTINI MOZZARELLA MEDLEY, Markets of Meijer SALAD ROTINI MOZZARELLA MEDLEY G&G
Meijer Inc. is voluntarily recalling multiple processed vegetable products following a supplier's recall due to potential contamination with Listeria monocytogenes.
Vegetable products including: ZUCCHINI AND SQUASH COMBO
Items purchased September 27, 2017 through October 20, 2017, the following UPC Codes:2-20785-00000-6     Sell by 10/15/2017
Vegetable products including: MIXED PEPPER BLEND
Items purchased September 27, 2017 through October 20, 2017, the following UPC Codes:  2-20787-00000-4  Sell by 10/13/2017
Vegetable products including: ZUCCHINI SQUASH
Items purchased September 27, 2017 through October 20, 2017, the following UPC Codes: 2-20786-00000-5, Sell by 10/15/2017
Vegetable products including:Large Veggie Tray  Medium Veggie Tray  Small Veggie Tray
Vegetable products including:   BRUSSELS SPROUTS SLICES
Items purchased September 27, 2017 through October 20, 2017, the following UPC Codes: 2-20782-00000-9; Sell by 10/13/2017
Vegetable products including: FIESTA TRAY WITH RED PEPPER HUMMUS
Items purchased September 27, 2017 through October 20, 2017, the following UPC Codes: 2-20582-00000-1, 22058200000  Sell by 10/15/17 and 10/17/2017  ,
Vegetable products including: CAULIFLOWER FLORETS 3 LB BAG   CAULIFLOWER FLORETTS (EDI)   CAULIFLOWER FLORETTS   CAULIFLOWER FLORETS PLU 4566    PRE-PACKAGED CAULIFLOWER FLORETS   CAULI FLORETS 3 LB BAG   CAULIFLOWER FLORETTS LB
Vegetable products including:   ASPARAGUS SPEARS &  ASPARAGUS SPEARS WITH GARLIC PARMESAN
1188 Asparagus units, 756 Asparagus with Butter units
Vegetable products including: Fresh Vegetable Tray with HUMMUS
744 units Sell by 10/17; and 312 units Sell by 10/15
Items purchased September 27, 2017 through October 20, 2017, the following UPC Codes: 22209100000, 2-22091-00000-8,   Sell by 10/15/2017 and 10/17/2017
Vegetable products including: BROCCOLI FLORETS 3 LB   BROCCOLI FLORETS LB   BROCCOLI FLORETS PLU 4548   PRE-PACKAGED BROCCOLI FLORETS   BROCCOLI FLORETS 3 LB BAG
Domestic: ILLINOIS, WISCONSIN    Foreign: None  VA/DOD: None
Bright Farms Inc. dba CHI Greenhouse LLC is initiating a voluntary recall of packaged produce due to the potential presence of E. coli.
Salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, 10/27/2017 and 10/28/2017.  BrightFarms Baby Kale (3 oz. package), UPC Code: 1115093816
Salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, 10/27/2017 and 10/28/2017.  BrightFarms Bulk 3# Kale Blend, UPC Code: 1115078087
BrightFarms Spinach Blend (4 oz. package)
Salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, 10/27/2017 and 10/28/2017.     Case 4oz each TENDERLY SWEET LOCAL SPINACH BLEND, UPC Code: 1115093817
BrightFarms Baby Spinach (4 oz. and 8 oz., and 3# packages)
The recall includes the below salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, and 10/27/2017, and 10/28/2017.   BrightFarms Baby Spinach (4 oz. and 8 oz., and 3# packages)    UPC Codes:1115078083, 1115093813, 1115078086
BrightFarms Baby Greens Blend (4 oz. and 8 oz. package)
Salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, 10/27/2017 and 10/28/2017.   BrightFarms Baby Greens Blend (4 oz. and 8 oz. package)   UPC Codes: 1115093818,1115093860
BrightFarms Basil (.75 oz. and 2 oz. package); BrightFarms Thai Basil (.75 oz. package); and BrightFarms Lemon Basil (.75 oz. package)
.75 oz Basil 727 Cases; Lemon Basil 63 cases .75 oz. ; Thai Basil 58 Cases .75 oz. ; 113 Cases 2 oz. Basil
Basil products, packaged in clear plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, and 10/27/2017.
BrightFarms Spring Mix (4 oz. and 8 oz., 3# packages);
salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, 10/27/2017 and 10/28/2017.   Spring Mix, 4 oz, 8 oz., and 3#  UPC Codes: 1115093815, 1115093861, 1115078085
BrightFarms Baby Arugula (4 oz. package)
Salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, 10/27/2017 and 10/28/2017.   BrightFarms Baby Arugula (4 oz. package), UPC Code: 1115093815
BrightFarms Baby Romaine Mix (4 oz. package)
Salad products packaged in clear, plastic clamshells with best by dates located on the label of the package: 10/24/2017, 10/25/2017, 10/26/2017, 10/27/2017 and 10/28/2017.  BrightFarms Baby Romaine Mix (4 oz. package), UPC Code: 1115093812
n Go refrigerated cases at Giant Eagle and Market District supermarkets.
Giant Eagle Voluntarily Recalls Breaded Shrimp Due to an Undeclared Egg Allergen. All lot codes up to and including best by October 24, 2017 of Giant Eagle brand Breaded Shrimp, prepared and sold from the Prepared Foods grab and go sections inside Giant Eagle and Market District supermarkets through October 19, 2017 have been voluntarily recalled by Giant Eagle due to an undeclared egg allergen.
up to and including Sell By: Oct 25 17.  PLU # 86815
Chicken of the Sea Pasteurized Crabmeat Lump Blend, Item #411820; Chicken of the Sea Pasteurized Crabmeat Claw, Item #370810; Jack's Catch Pasteurized Crabmeat Jumbo Lump Item #193980; Jack's Catch Pasteurized Crabmeat Lump, Item #199830. All packaged in 1 LB or 16 OZ tin cans.
The firm is initiating a recall due to potential temperature abuse to product during transit.
Item #193980   Manufacturer Code Number: 93981-10 and Best by Date: 10/08/2018; Item #411820   Manufacturer Code Number: 411821238 and Best by Date(s): 09/02/2018; 10/28/2018; 11/08/2018; Item #370810   Manufacturer Code Number: 10843237008152 and Best by Date(s): 09/19/2018; 11/18/2018; Item #199830   Manufacturer Code Number: 93982-10 and Best by Date: 10/03/2018
ROSA Surgical Device 2.5.8.     It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and  Germany
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
Estriol, For Prescription Compounding,  packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
cGMP Deviations: lack of quality assurance at the API manufacturer.
Domestic: IL, IN, KY, MI, OH, WI      Foreign: none  VA/DOD: None
Dark chocolate covered coffee beans MEIJER BULK DARK CHOCOLATE COFFEE BEANS 18 OZ Clear plastic clam-shell, 12 packages per case
Meijer  initiated a voluntary recall of Meijer Bulk Dark Chocolate Almonds, Meijer Bulk Dark Chocolate Cashews, and Meijer Bulk Dark Chocolate Coffee Beans due to a supplier's recall for undeclared allergen milk.
MEIJER BULK DARK CHOCOLATE CASHEWS	18 OZ Clear plastic clam-shell, 12 packages per case
MEIJER BULK DARK CHOCOLATE ALMONDS 18 OZ, Clear plastic clam-shell,12 packages per case
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Dark Chocolate Almonds;  Packaged in 11 oz. pre-packed plastic cups;  UPC: 6-51433-66300-5  Also sold in 20 lb. bulk.  Sold in bulk bins at Albertsons/Safeway/Vons/Pak 'N Save) - PLU 21881;  UPC: 6-51433-10004-3  Bulk bins at Nugget Markets - PLU 6630;  UPC: 6-51433-10004-3    Ingredients: Dark Chocolate (sugar, chocolate liquor, cocoa butter, chocolate liquor processed with alkali, soy lecithin [an emulsifier], salt, natural flavor), Almonds, water, gun Arabic, Confectioner's Glaze, Modified Starch (tapioca), Coconut oil.  Contains: Almonds, soy and other tree nuts  May contain wheat, peanuts, milk    Distributed by DSD Merchandisers, Inc., Livermore, CA 94568
Firm was notified by their supplier that Dark Chocolate Almonds were being recalled due to undeclared milk.
Product distributed to distributors in AR, CO, IA, IL, KS, KY, LA, MI, MO, MN, MS, and ND
West Creek Original BBQ Sauce, Net Contents 1 Gal, Distributed by Performance Food Group, Richmond, VA packaged in plastic jugs.
Products potentially contain undeclared egg.
West Creek Sweet BBQ Sauce, Net Contents 1 Gal, Distributed by Performance Food Group, Richmond, VA packaged in plastic jugs.
BBQ Sauce, 200/0.88 oz Net Wt 11 lbs, Packed exclusively for Carl's Jr. Restaurants LLC, Hardee's Restaurants LLC, Carpinteria, CA. Packed packaged in plastic cups.
Monarch Worcestershire Sauce, Net 1 gallon, Distributed by US Foods, Inc. Rosemont, IL, packaged in plastic jugs.
Texas Roadhouse Barbecue Sauce, NET 3/2 gallon, Mfg. exclusively for: Texas Roadhouse Restaurants, Louisville, KY, packaged in plastic pouches.
All direct to consumer Nationwide and worldwide, including govt/military consignees.
Unexpired product distributed between Oct 1, 2015 and Oct 25, 2017
Dark Chocolate Coffee beans packaged in   Bulk  4 oz. Plastic Pouch   8.25 oz. Plastic Pouch  8.25 oz. Plastic Cup  17 oz. Family Size Plastic Pouch    Aurora Brand and Store Branded Labeling Include: AG Supermarkets, Belmont Market, Boiceville Market, Deciccos, Grauls Market, Gourmet Garage, Harvest Co  Op Market, Hurley Ridge, Lees Supermarket, Morton Williams, Palmers Market, Walter Stewart, Windfall Market and Whole Food Market.
BEST IF USED BY DATE CODE RANGE: 11/01/16  7/30/18
Dark Chocolate Almonds packaged in:  4 oz. Plastic Pouch,   9 oz. Plastic Cup,  9 oz. Stand Up Plastic Pouch,  12 oz. Square Plastic Tub,  17 oz. Family Size Plastic Pouch.    Aurora Brand and Store Branded Labeling Include: AG Supermarkets, Belmont Market, Boiceville Market, Decicco s, Graul s Market, Gourmet Garage, Harvest Co   Op Market, Hurley Ridge, Lees Supermarket, Morton Williams, Palmers Market, Walter Stewart, Windfall Market and Whole Food Market.
Aurora Brand Dark Chocolate  Cherries packaged in:  8.5 oz. Plastic Cup  11 oz. Square Plastic Tub
Dark Chocolate Cranberries packaged in:     Bulk  3.5 oz. Plastic Cup  4.75 oz. Plastic Pouch   9 oz. Plastic Cup  9 oz. Plastic Pouch  11 oz. Square Plastic Tub  18 oz. Family Size Plastic Pouch   26 oz. Plastic Tray    Aurora Brand and Store Branded Labeling Include: AG Supermarkets, Belmont Market, Boiceville Market, Deciccos, Grauls Market, Gourmet Garage, Harvest Co  Op Market, Hurley Ridge, Lees Supermarket, Morton Williams, Palmers Market, Walter Stewart, Windfall Market and Whole Food Market.
Dark Chocolate Turbinado Almonds w/ Sea Salt packaged in :  7 oz. Plastic Cup  Packaged under the following:   Aurora Brand and  Store Branded Labeling Include: Gourmet Garage,  Lee's  Supermarket
Domestic: AL  AZ  CA  CO  IA  ID  IL  LA  MA  MN  MO  NC  NE  NH  NY  OH  SD  TX  VA  WI  WY
Rucker s Wholesale & Service Co . initiated a voluntary recall on 10/31/2017 of Uncle Buck's and Family Choice Dark Chocolate Peanuts following a supplier's recall due to undeclared allergen milk.
Item #10226, with package UPC 0 52545 10226 8, all codes prior to 103018.
(1)Setton Farms Deluxe Dark Chocolate Almonds 20oz.  plastic tubs  UPC: 034325078741  (2) Setton Farms Deluxe Dark Chocolate Almonds 14oz .  plastic stubs  UPC:034325747661
(1) Setton Farms Deluxe Dark Chocolate Raisins 24oz. plastic  tub  UPC:034325078758  (2) Setton Farms Deluxe Dark Chocolate Raisins 16oz.. plastic tub   UPC:034325147669
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Nature's Touch US frozen Organic Whole Beans, 10-oz., UPC code 8 7366800141
Listeria monocytogenes found in a sample of this product.
Best By date code range: 2017 JUN 04 - 2019 JUN 21
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
Superpotent drug: out of specification result for potency
Distributed locally to 21 consignees.  No foreign/VA/govt/military consignees.
Veggie Wrap, Net Wt: 8 oz/227g, UPC 7 62089 10655 3,  Etai's, individual plastic container, keep under refrigeration
Etai's Food, Inc. is recalling caprese panini and veggie wrap due to undeclared tree nuts.
Caprese Panini, Net WT: 7 oz/198g, UPC 7 62089 10728 4, Etai's, individual plastic container, keep under refrigeration
Blood product collected from a donor who traveled to a malarial endemic area, was distributed.
Source Plasma units, not meeting product specifications, were distributed.
Source Plasma unit, not meeting product specifications, was distributed.
Germany, Federal Republic of; Switzerland
Blood products, in which donor suitability was not adequately determined, were distributed.