🍔 Food 💊 Drugs 🏥 Medical Devices
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492-12 UPC 3 16729 49212 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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Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 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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Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2 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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Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5. 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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Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 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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Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 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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BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2 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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BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-202-16 UPC 3 16729 20216 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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BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 2; 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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BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 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
View Details
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