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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Rantidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.
Recall Number D-1229-2014
Classification Class II
Code Info Lot 12AN118A, Exp 10/14
Product Distributed Qty 2904 bottles
Reason For Recall Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.

Event Detail

Event Id 67776
Product Type Drugs
Status Ongoing
Recalling Firm Glenmark Generics Inc., USA
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide