Drug product
Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
D-0521-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 Bottles
- Official record key
drug-enforcement:D-0521-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: Lot: F1021I; H3122J, Exp 4/30/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations