Drug product
Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99
D-0290-2021
Product summary
- Event
- Event 87193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1296 bottles
- Official record key
drug-enforcement:D-0290-2021
Official wording
Reason: Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Code information: Lot #: P2000467, Exp 7/2022
Distribution pattern: TX, CA, GA, PA
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets