Drug product
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
D-0511-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 158 Bottles
- Official record key
drug-enforcement:D-0511-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: Lot #: A0523D, Exp 5/31/2024, F14220, Exp 7/31/2023, J0622Q; Exp 1/31/2024.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations