August 2013 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-884-2013 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on August 2, 2013 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-884-2013

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.
Initiated
08-02-2013
Reported
08-21-2013
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65885
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-19-2014
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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