🍔 Food 💊 Drugs 🏥 Medical Devices
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20. Class II

Reason: Subpotent Drug: low Anti-Factor IIa potency.

B. Braun Medical Inc 20230301 Terminated
Distributed: Nationwide in the USA
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Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326 Class II

Reason: Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

Apotex Corp. 20230301 Completed
Distributed: Nationwide in the USA
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PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1. Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Volt Candy Wholesale Club 20230213 Terminated
Distributed: Nationwide in the USA
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Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4 Class II

Reason: Packaging defect: observed packaging defect, blister packaging inadequately sealed.

The Harvard Drug Group 20230223 Terminated
Distributed: Distributed Nationwide in the USA
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rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC 3 16729 23801 4 Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. 20230207 Terminated
Distributed: United States including Puerto Rico and Canada
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rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC 3 16729 23701 7 Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. 20230207 Terminated
Distributed: United States including Puerto Rico and Canada
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rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC 3 16729 23601 0 Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. 20230207 Terminated
Distributed: United States including Puerto Rico and Canada
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rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3 Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. 20230207 Terminated
Distributed: United States including Puerto Rico and Canada
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rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6 Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. 20230207 Terminated
Distributed: United States including Puerto Rico and Canada
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rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9 Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. 20230207 Terminated
Distributed: United States including Puerto Rico and Canada
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