FDA Drug recall D-884-2013

Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist

FDA Drug
Class II
terminated
Published 2013-08-21

On 2013-08-21 the FDA classified a Class II recall of Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist by Dr Reddy S Laboratories, citing microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-884-2013
Classification	Class II
Status	terminated
Initiated	2013-08-02
Published	2013-08-21
Last updated	2026-09-13 11:51 UTC
Company	Dr Reddy S Laboratories
Distribution	US

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-884-2013%22

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