April 2016 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-1058-2016 - Failed impurities/degradation specification

This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on April 22, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1058-2016

Reason for Recall
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Initiated
04-22-2016
Reported
07-06-2016
Quantity
84,240 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74220
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
04-26-2017
Product Description About Product Description
Full technical description of the product.
CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523

Batch or Lot Expiration Information

Lot# 79405008A, 79405008B, 79405008C, Exp 05/2017