Drug product
Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724
D-0491-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 bottles
- Official record key
drug-enforcement:D-0491-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: L200801
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations