🍔 Food 💊 Drugs 🏥 Medical Devices
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX Class I

Reason: Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis

Abrams Royal Pharamacy 20131219 Terminated
Distributed: Nationwide and to Canada
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LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Class I

Reason: Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. 20140528 Terminated
Distributed: Michigan and Wisconsin
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adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Class I

Reason: Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. 20140528 Terminated
Distributed: Michigan and Wisconsin
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del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Class I

Reason: Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. 20140528 Terminated
Distributed: Michigan and Wisconsin
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PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Class I

Reason: Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. 20140528 Terminated
Distributed: Michigan and Wisconsin
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Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02. Class III

Reason: Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

Perrigo Holland Inc 20140819 Terminated
Distributed: U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.
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Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05. Class III

Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Mylan Pharmaceuticals Inc. 20140619 Terminated
Distributed: Nationwide
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VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451. Class II

Reason: Customer complaints for failure to deliver the dose.

Alkermes, Inc. 20140304 Terminated
Distributed: Nationwide
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Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11. Class III

Reason: Failed Impurity/Degradation Specification; 12-month stability time point

Novel Laboratories, Inc. 20140620 Terminated
Distributed: Nationwide
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fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04 Class II

Reason: Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Healix Infusion Therapy, Inc. 20140627 Terminated
Distributed: Texas and Georgia
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