April 2020 FDA Recall Esomeprazole Magnesium by Dr. Reddy's Laboratories, Inc.
D-1256-2020 - Discoloration
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on April 24, 2020 for the product Esomeprazole Magnesium. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1256-2020
Discoloration: product contains brown pellets
04-24-2020
05-06-2020
1752 bottles
Recall Profile & Regulatory Data
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.
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 within the United States
05-13-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
Batch or Lot Expiration Information
Lot# : C900642, Exp. 06/2020
