Drug product
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
D-1047-2020
Product summary
- Event
- Event 85184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1416 bottles
- Official record key
drug-enforcement:D-1047-2020
Official wording
Reason: Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Code information: Lot#: AA33617, Exp 03/2021
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance