Drug recall D-1342-2014
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
Reason for recall
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Lots and codes
Lot #: MN9081, Expiry: 09/2015
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- 10,200 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 8, 2014
- Terminated
- February 26, 2016
Related products
- Promethazine Hydrochloride – drug information
- NDC 68382-042 Promethazine Hydrochloride · Promethazine Hydrochloride 50 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-041 Promethazine Hydrochloride · Promethazine Hydrochloride 25 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-040 Promethazine Hydrochloride · Promethazine Hydrochloride 12.5 mg/1 · Zydus Pharmaceuticals USA Inc.