March 2016 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-0841-2016 - Failed Impurities/Degradation Specifications; 12 month stability time point
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on March 30, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; 12 month stability time point. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0841-2016
Failed Impurities/Degradation Specifications; 12 month stability time point
03-30-2016
05-18-2016
50,280 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Batch or Lot Expiration Information
Lot# Lot number C500691, exp 12/2016
