Recalling Firm
Valeant Pharmaceuticals North America LLC

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
AZ, CA, FL, GA, HI, IL, IN, MA, MD, MI, MN, NV, NY, OH, PA, SC, WA, WI, British Columbia (Canada)
Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.
USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, WA, WI, WV, WY, Hawaii and Puerto Rico Canada.
AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa South Korea Spain Sweden Switzerland Thailand Turkey United Kingdom
Product was shipped to the following sates: CA & OH
MO, ND, FL, OR, NC, MI, FL, CO, NY, OH, AZ, UT, MN, CA, TX, RI, NJ, VA
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV
One location each in CA and HI; one location in MX
WA, OR, TX, CA, UT, NV, AZ, NY, MA, CT, CO, WV, MD, VA, NC, MD, PA..
AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada
37 Operations received product. Types of operations Airport and/or Toll way retail.

Product Description
Against the Grain PULLED BEEF with Gravy. Slow Simmered, Grain Free. NET WT. 12 OZ
Barnsdale Farms, HoundsTooth and Mac's Choice Brand Pig Ears, individually shrink-wrapped, 6-pack, 12-pack, 25-pack and 100-pack plastic bags
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Conductivity Standard Solution, 14.0 mS/cm @ 25 degrees Celsius, specification +/- 0.02 mS, Discard 30 days after opening, Sodium Chloride (CAS# 7647-14-5) and Deionized Water (CAS# 7732-18-5), 32 oz (950 mL)
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).
Fat Cat Purry-Purry Sauce, Net Weight: 5 oz (141g)
Cristina brand Egg Crackers (Galletas de Huevo), 4OZ, Clear plastic/film type bag, ready-to-eat, dry/ambient storage
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
GnuPharma Fit 100% Herbal Supplement 60 Capsules
GnuPharma Foundation 100% Herbal Supplement 60 Capsules
GnuPharma ECS Herbal Tea Relief SAMPLE ONLY
GnuPharma Sleep 100% Herbal Supplement 60 Capsules
GnuPharma Stress 100% Herbal Supplement 60 Capsules
GnuPharma Relief 100% Herbal Supplement 60 Capsules
AdvancePierre Foods TURKEY BOLOGNA & CHEESE 4.0 oz Contains: Wheat, Soy, Milk AdvancePierre Foods, Inc. 9990 Princeton Glendale Rd. Cincinnati, OH 45246 UPC 00071421681260
Classic Delight Ham & Cheese Net Wt. 4.0 oz (113 g) Contains: Wheat, Soy, Milk Distributed by Classic Delight Inc., St. Marys, OH 45885 UPC 0 20018 03226 8
Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination
Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Code: 425FS; Keep Frozen; Gourmet Salmon Burgers; Net Wt. 6.40 lbs, 24-4.25 OZ patties; Wick's Kitchens, Trainer, PA 19061; Lot # GSB030217, Sell By 9/2/18; Lot # GSB031017, Sell By 9/10/18; Lot # GSB032817, Sell By 9/28/18; Lot # GSB040417, Sell By 10/4/18; Lot # GSB050417, Sell By 11/4/18; Culinary Circle; Gourmet Salmon Cakes; Net Wt. 8 oz.; 2 -4 OZ Cakes; Distributed by Supervalu, Inc., Eden Prairie, MN 55344; Lot # GSB012317, Sell By 7/23/18; Lot # GSB020917, Sell By 08/9/18; Lot # GSB022217, Sell By 08/22/18; Lot # GSB040417, Sell By 10/4/18; Lot # GSB050417, Sell By 11/4/2018;
Code: LM290; Keep Frozen; Lucky's Maryland Style Crab Cakes: Net Wt. 13.5 lbs; 72-3OZ; packed for Lucky's Markets, Niwot, CO 80503; Lot # LM042717; - Sell By 10/27/18
WICK'S (4) Oven-Ready; Southern Style Shrimp Cakes; Net Weight 10 OZ; 4 - 2.5 OZ Cakes; Distributed by: Wick's Kitchens, Trainer, PA 19061; Code: 144R4 Lot # CAJ011817, Sell By 08/22/18; Lot # CAJ022217, Sell By 09/22/18; Lot # CAJ050417, Sell By 11/4/18;
FIT&FOCUSED SUPPLEMENTS CLA 3000mg CONJUGATED LINOLEIC ACID LEAN BODY FORUMLA 135 SOFTGELS; UPC: 7 28028 44036 2
LA PASTA Dairy-Free Mushroom Ravioli, UPC 07970602217-3 , LOT #1536
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
New England Natural Bakers Organic Muesli -5lb and 25 lb. cases UPC: 00046689225013
Evoke Organic Muesli Classic Swiss 12 oz. pouch UPC: 853305003081
Millville Fruit & Nut Whole Grain Granola - 16 oz .carton Distributed by Aldi Inc. Batavia, IL 60510 UPC:041498205232
Evoke Organic Muesli Athlete Fuel -12 oz .pouch UPC: 853305003029
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Pacific Wave Frozen Tuna Loins; 30# case. Imported by Unified Seafood Co., Inc. www.unifiedseafood.com
Masas Gourmet Curry Coconut Sauce, packaged in a glass jar with gold metal cap, net wt. 12 oz. (355 mL), UPC 786764412227.
Masas Gourmet Sweet and Sour Sauce, packaged in a glass jar with gold metal cap, net wt. 12 oz. (355 mL), UPC 786764406783
Masas Gourmet Pulled Pork BBQ Sauce, packaged in a glass jar with gold metal cap, net wt. 18 oz. , UPC 786764550035.
Standex International Bakers Pride Microwave Ovens Model E300
Cost Plus World Market My Favorite Macadamia Pancake and Waffle Mix, 24 oz. UPC Codes: 496960
All in Nutrition Wicked Maple Energy Bars 18 g protein, 9 g net carbs, Gluten Free, GMO Free, 100% natural 1.94 oz. (55g); YouBar Inc. Monterey Park, CA.
Rassel-Daigneault Family Chiropractic; Cashew Quinoa Cherry Chocolate Protein Bar GMO, Vegan, Gluten Free JD-RDCQC-WP-F-V1 1.55 oz. (44g); YouBar Inc. Monterey Park, CA.
Nutrifuel - Figgilicious Nutrition Bar Gluten Free, All Natural, Vegan, 9 g protein 1.76oz. (50 g) YouBar Inc. Monterey Park, CA.
OnPoint Chocolate Flavor Nutrition Bar; Contains Grass fed whey protein, 20 g protein, High Fiber 2.46 oz. YouBar Inc. Monterey Park, CA.
OutClass Nutrition Cranberry Cashew Protein Bar; No Artifical Colors or flavors 2.15 oz. (65 g) YouBar Inc. Monterey Park, CA.
POZZIBLE Chocolate Chips; 20 g protein bar; Gluten Free; no Sugar added 2.43 oz. (69 g) YouBar Inc. Monterey Park, CA.
The Only Bar Cherry Cashew, Nutrition Bar Gluten Free, Vegan, 9 grams of pant program, 100% Natural 1.55 oz. (44g); YouBar Inc. Monterey Park, CA.
Nancy Adler Nutrition Nancy's Granola Bar 1.58 oz. (45g) Please keep refrigerated Handmade by YouBar Inc. Monterey Park, CA.
YouBar, High Protein Cherry Cashew Chia; 3 G Sugar, Non GMO, Vegan, Superfood 1.44 oz. (41 g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
GDBA Protector Bar - Vanilla Coconut; Your Choose the Ingredients, Your Name the Bar, You Enjoy it! 1.58 oz. (45g); JT-JTGDBAVC-WP-F-V1 YouBar Inc. Monterey Park, CA.
YouBar High Protein Bar Chocolate Almond Bar. 12 bars per box 2 Grams Sugar, Non GMO, Vegan, Superfood 1.55 oz. (45g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Koona Positive Nutrition - Zesty Lemon Cashew; Plant Based protein Snack 2.11oz. (60 g) YouBar Inc. Monterey Park, CA.
YouBar Whole Food Bar, Chocolate Peanut Butter; 1.58 oz. (45g); Gluten Free, Non GMO, Vegan; 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Nutrifuel - Berrylicious Nutrition Bar Gluten Free, All Natural, 15 g protein 2.04oz. (58 g) YouBar Inc. Monterey Park, CA.
DR. MORRISON - COCONUT CACAO BAR: Whole Food Bar, Gluten Free, Non GMO, Vegan 1.69 oz. (48 g) YouBar Inc. Monterey Park, CA.
Emmanuels Earthly Goods - Oatmeal Raisin Nutrition Bar; Good Source of Protein, GMO Free, Gluten Free, Vegan; 1.51 oz. (43 g) YouBar Inc. Monterey Park, CA.
Rassel-Daigneault Family Chiropractic; Double Chocolate Protein Bar Paleo Friendly, 20 g or protein, Gluten Free JD-RDDC-WP-F-V1 2.56 oz. (70g); YouBar Inc. Monterey Park, CA.
YouBar Whole Food Bar - Cashew Cherry (SKU YB-CHC-001) Packed in a plain white synthetic packaging and under YouBar label. 12 bars per box. Non GMO. Gluten Free, Vegan 1.58 oz. (45g): Manufactured by YouBar Inc. Monterey Park, CA.
Nancy Adler Nutrition Nancy's Cookie Bar 1.58 oz. (45g); Please keep refrigerated Handmade by YouBar Inc. Monterey Park, CA.
YouBar Paleo Protein Vanilla Coconut Protein Bar Bar. 12 bars per box 1.58 oz. (45g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Milk Drunk Energy Bar - Honey Almond Chocolate Chip; The energy bar for breast feeding mama's 10 g protein, 12 g fiber, 220 calories, gluten Free, Non GMO 2.04oz. (58 g) YouBar Inc. Monterey Park, CA.
YouBar Coffee Bar, Carmel Macchiato; Imagine Better Coffee: Gluten Free, Fair Trade Coffee 12 bars per box 1.58 oz. (45g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Reset360 - CASHEW CHOCOLATE CHIP Vegan Nutrition Bar; Non GMO, Vegan; 2 g sugar, 8 g protein,10 g fiber 1.76 oz. (50 g) YouBar Inc. Monterey Park, CA.
Nancy Adler Nutrition Nancy's Nutrition Bar 1.58 oz. (45g); Please keep refrigerated Handmade by YouBar Inc. Monterey Park, CA.
Rassel-Daigneault Family Chiropractic; Vanilla Coconut Cacao Protein Bar GMO, Vegan, Gluten Free 1.55 oz. (44g); JD-RDVCC-WP-F-V1 YouBar Inc. Monterey Park, CA.
YouBar High Protein Bar, Vanilla Chocolate Chip; 1.51 oz. (43 g) 2G sugar, Non GMO, Vegan, Superfood; Manufactured by YouBar Inc. Monterey Park, CA.
Too Busy To Eat - The Pure Protein Bar - Double Chocolate Chip; Made with Grass fed whey protein, Gluten Free, 20 g fiber, 20 g protein 2.46 oz. (70 g) YouBar Inc. Monterey Park, CA.
POZZIBLE - Vanilla Coconut; 20 g protein bar; Gluten Free; no Sugar added 2.29 oz. (65 g) YouBar Inc. Monterey Park, CA.
Nutrifuel - Paleo Nutrition Bar Gluten Free, All Natural, 15 g protein 1.90oz. (54 g) YouBar Inc. Monterey Park, CA.
POZZIBLE Goji Crisp; 20 g protein bar; Gluten Free; no Sugar added 2.25 oz. (64 g) YouBar Inc. Monterey Park, CA.
Nutrifuel - Chocolicious Nutrition Bar Gluten Free, All Natural, 10 g protein 1.58 oz. (45 g) YouBar Inc. Monterey Park, CA.
YouBar High Protein Coco-Coconut Protein Bar; Gluten Free, High Fiber, No Sugar added Bar. 12 bars per box 1.58 oz. (45g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Veganic Brownie Batter Bomb Nutrition Bar Vegan, 15 g protein, Non GMO, Gluten Free 2.18oz. (62 g) YouBar Inc. Monterey Park, CA.
Futaba Sesame Hijiki Rice Seasoning; 2.29 oz. glass jar; 4 902533 023173
PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
Sugar Plum Cake 16 oz packaged in a glass jar
Red Chili Wild Plum Dipping Sauce NET WT 10 oz. packaged in a glass jar
Peanut Patties 2.5 oz. wrapped in cellophane
Wild Plum Apricot Bread 16 oz packaged in a glass jar
A Texas Praline 14 oz. wrapped in cellophane
Special Dark Chocolate Cake 16 oz packaged in a glass jar
A Creamy Praline 2 oz. wrapped in cellophane
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
BAKEMARK CANADA White Cross Topping Mix 10 lb 4.54 kg; BakeMark NDS Item Code: 50623; UPC: 0 64278 50623 7
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48
Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48
Cape Cod Cranberry Trail Mix; 25 lbs. bulk containers; cardboard box; expiration date 11/18/17.
Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

Product Quantity
97 distributed worldwide, 12 distributed in United States
Approximately 420 units in storage with Amazon and 40 units to consumer
226 - 7 Whole Box Locations, 38 Variety Box Locations
5 boxes of 12 bars each for plain packaging: 612 YouBar brand
288 - 14 (Whole Box Locations), 30 VIP Sample Box Locations
310, 9 whole box locations, 38 Variety Box Locations
30 cases (20/2 lbs. package per case) AND 32 cases (10/4 lbs. packages per case)

Reason for Recall
Product sampled and tested positive for the barbiturate pentobarbital.
Potential to be contaminated with Salmonella.
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Undeclared milk detected in product and inaccurate Contains statement on label.
Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures.
Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
Product contains undeclared soy lecithin.
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli)
Product test positive for Listeria monocytogenes
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.
The firm's breaded seafood products were breaded using an ingredient, which was recalled due to undeclared milk.
Product may be contaminated with Salmonella.
The product is labeled as gluten-free, but contains gluten.
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Product may be contaminated with Listeria monocytogenes
Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
Direct customer tested tuna loins and had a positive result for Hepatitis A.
Curry Coconut Sauce is recalled because the Ingredients Statement declared dry whey but the Contains statement does not declare milk.
Sweet and Sour Sauce is recalled due to undeclared milk.
Pulled Pork BBQ Sauce is recalled because the Ingredients Statement declared dry whey but the Contains statement does not declare milk.
It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks.
Potential for Listeria Monocytogenes contamination
Firm was notified by supplier that cashew butter used in protein bars is under recall due to the potential of Listeria monocytogenes.
Firm discovered that seasoning product imported from Japan lacks an English language label and does not declare Wheat, Soybean and Fish (Bonito) allergens.
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Product declares butter on the label but not milk.
Product contains undeclared wheat from the ingredient: soy sauce.
Product declares cream on the label but not milk.
Product declares flour on the label but not wheat.
Product declares butter and cream on the label but not milk.
When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.
Product may be contaminated with E. coli O121.
A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.
Lack of Assurance of Sterility; media fill failure at manufacturer
The firm was notified that the date vendor had a positive test for Listeria in the vendor's facility. Dates are an ingredient in the product. HMS Host is initiating a precautionary voluntary recall.
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Undeclared wheat. Sooji Coarse is recalled because product contains Semolina but wheat is not declared on label.
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

Code Info
All product manufactured between December 1, 2015 and January 14, 2017 and bearing expiration dates of December 2019 through January 2021. Second part of UPC Code: 80001
Kits that include affected 9731958 INSTALL CD: INST SET 9734833 UNIVERSAL NAVLOCK, INST SET 9734834 CAPSTONE TRIALS, INST SET 9734835 CLYDESDALE TRIALS, INST SET 9734836 TLIF/DLIF INSERTER, INST SET 9735283 SOLERA 5.5/6.0 DRIVERS, INST SET 9735284 SOLERA NONCAN TAPS, INST SET 9735285 SOLERA ILIAC TAPS, TAPS KIT 9735465 SOLERA AWL-TIP TAPS, REF SET 9735500 SPINE REFRENCING, UPGRD KIT 9735522 SPINE REVISION, INSTR SET 9735607 VERTEX SELECT
Lot No. ML-C14-1352; Exp. Date 28APR2018;
products manufactured prior to May 8th, 2017.
(SKU YB-CHC-001) Expiration date: 11/26/2017 - plain white wrapping: YouBar brand: Code 0977-02, Expiration date 10/04/2017.
All lots distributed between June 19, 2016 and June 19, 2017.