Drug product
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
D-1342-2014
Product summary
- Event
- Event 68285
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,200 bottles
- Official record key
drug-enforcement:D-1342-2014
Official wording
Reason: Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Code information: Lot #: MN9081, Expiry: 09/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets