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Recall Observatory FDA recall evidence

Drug product

Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA.

D-0371-2023

February 07, 2023

Class II

Product summary

Firm
Accord Healthcare, Inc.
Event
Event 91657
Status
Terminated
Classification
Class II
Quantity
256,106 bottles
Official record key
drug-enforcement:D-0371-2023

Official wording

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

Code information: Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613, R2101614, Exp. Date 11/30/2023; R2200222, R2200221, R2200223, Exp. Date 1/31/2024; R2200795, R2200713, R2200701, R2200711, R2200712, R2200756, R2200757, R2200754, R2200755, Exp. Date 5/31/2024; R2200945, R2200943, Exp. Date 6/30/2024;

Distribution pattern: United States including Puerto Rico and Canada

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations