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

FDA recall notice · announced May 28, 2014 · Zydus Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

Notes

Distribution: Nationwide
Lot/code information: Lot #: MN9081, Expiry: 09/2015
Quantity: 10,200 bottles
Status: Terminated
Products in this recall event:
- 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: (D-1342-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.