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U.S. Department of Health and Human Services

Enforcement Report - Week of August 21, 2013

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Product Detail

Product Description Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34
Recall Number D-884-2013
Classification Class II
Code Info a)Lot: 5055822, exp. 03/13; 5056317, exp. 03/15; and 5056507, exp. 04/15 b)Lot: 7956571C, exp. 04/15 c)Lot: 7956572A, exp. 04/15
Product Distributed Qty
Reason For Recall Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.

Event Detail

Event Id 65885
Product Type Drugs
Status Ongoing
Recalling Firm Dr. Reddy's Laboratories, Inc.
City Bridgewater
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide