Drug product
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
D-0512-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a) 375 Bottles b) 323 Bottles
- Official record key
drug-enforcement:D-0512-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: a) Lot: B1522B, Exp 4/30/2023; lot:C0222H, C0322B, Exp 5/31/2023; lot: E1022H, F13220, H2222P, Exp 6/30/2023; Lot: I1422V, K01220, Exp 12/31/2023; Lot: L2722H, Exp 3/31/2024; b) Lot:C0322B, Exp 5/31/2023; lot:H1122G, 12322Q, Exp 6/30/2023; lot: J1222U, Exp 12/31/2023.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations