Drug product
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
D-0832-2020
Product summary
- Event
- Event 84814
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,056 bottles
- Official record key
drug-enforcement:D-0832-2020
Official wording
Reason: Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Code information: Lot #: ATA318099C, Exp 12/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets