The Indian pharmaceutical company Dr. Reddy’s Laboratories has initiated a voluntary recall of five lots of ranitidine hydrochloride tablets (150 mg, over-the-counter [OTC]) due to microbial contamination. The Class II recall was posted on FDA’s weekly enforcement report for Aug. 21, 2013 and initiated on Aug. 2, 2013. Ranitidine is used to treat gastroesophageal reflux disease.
The recall, which is nationwide in the United States, was due to microbial contamination of nonsterile products. A lot of raw material used in the manufacture of ranitidine was positive for Pseudomonas sp.
The ranitidine hydrochloride tablets, USP 150 mg, OTC, were distributed as Equate brand Maximum Strength Acid Reducer (65-count bottle), Equaline brand Maximum Strength Heartburn Relief, and Wal-Zan brand 150, Maximum Strength (24- count bottle) and distributed respectively by Wal-Mart Stores, Supervalu, and Walgreen Co.
The affected lots were: 5055822, expiration date 03/13; 5056317, expiration date 03/15; 5056507, expiration date 04/15; 7956571C, expiration date 4/15; and 7956572A, expiration date 04/15.