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FDA Enforcement Records

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Browse published US FDA drug-enforcement recall records. Filter by country, classification, status, or date.

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Showing 2501–2525 of 4,707 active FDA enforcement records · Country: united states

  • Class IICompleted
    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 · Mar 15, 2023 · United States
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  • Class ITerminated
    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. · Mar 8, 2023 · United States
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  • Class IITerminated
    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 · Mar 8, 2023 · United States
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  • Class IITerminated
    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 · Mar 8, 2023 · United States
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  • Class IITerminated
    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 · Mar 8, 2023 · United States
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  • Class IITerminated
    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 · Mar 8, 2023 · United States
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  • Class IITerminated
    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 · Mar 8, 2023 · United States
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  • Class IITerminated
    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 · Mar 8, 2023 · United States
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  • Class IITerminated
    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 · Mar 8, 2023 · United States
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  • Class IITerminated
    rOPINIRole Tablets USP 0.25 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 16729-232-01, UPC 3 16729 23201 2; · Mar 8, 2023 · United States
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  • Class IITerminated
    Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0 · Mar 8, 2023 · United States
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  • Class IITerminated
    Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7 · Mar 8, 2023 · United States
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  • Class IITerminated
    Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7. · Mar 8, 2023 · United States
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  • Class IITerminated
    Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA · Mar 8, 2023 · United States
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  • Class IITerminated
    Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2. · Mar 8, 2023 · United States
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  • Class IITerminated
    Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8. · Mar 8, 2023 · United States
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  • Class IITerminated
    Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-521-11, UPC 3 16729 52111 6. · Mar 8, 2023 · United States
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  • Class IITerminated
    Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA · Mar 8, 2023 · United States
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  • Class IITerminated
    Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA · Mar 8, 2023 · United States
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  • Class IITerminated
    Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA · Mar 8, 2023 · United States
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  • Class IITerminated
    Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA · Mar 8, 2023 · United States
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  • Class IITerminated
    Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1. · Mar 8, 2023 · United States
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  • Class IITerminated
    Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA · Mar 8, 2023 · United States
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  • Class IITerminated
    Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA · Mar 8, 2023 · United States
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  • Class IITerminated
    Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA · Mar 8, 2023 · United States
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Only the latest five years of published US FDA drug-enforcement recall records are indexed. The displayed entity is an FDA-recorded recalling firm; country, city, and state are source attributes, not proof of manufacturer, parent company, ownership, legal entity, safety, compliance, or approval.