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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description 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
Recall Number D-1342-2014
Classification Class II
Code Info Lot #: MN9081, Expiry: 09/2015
Product Distributed Qty 10,200 bottles
Reason For Recall Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

Event Detail

Event Id 68285
Product Type Drugs
Status Ongoing
Recalling Firm Zydus Pharmaceuticals USA Inc
City Pennington
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide