Recalls / Class II

Class IID-884-2013

Product

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

Affected lot / 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

Why it was recalled

Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.

Recalling firm

Firm

Dr. Reddy's Laboratories, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

200 Somerset Corporate Blvd Fl 7th, Bridgewater, New Jersey 08807-2862

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-08-02

FDA classified

2013-08-12

Posted by FDA

2013-08-21

Terminated

2014-03-19

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-884-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.