Drug product
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
D-0522-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 82 Bottles of 90 Tablets
- Official record key
drug-enforcement:D-0522-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: Lot: C2222P, D1522L, E3122D, G2522J, Exp 9/30/2023; Lot: J1222R, Exp 10/31/2023.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations