Drug product
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
D-0878-2018
Product summary
- Event
- Event 80208
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,397 bottles
- Official record key
drug-enforcement:D-0878-2018
Official wording
Reason: Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Code information: Lot #: T800064, Exp 12/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance