🍔 Food 💊 Drugs 🏥 Medical Devices
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; 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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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 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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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 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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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. 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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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 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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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. 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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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. 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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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. 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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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 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
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 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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