February 2019 FDA Recall Esomeprazole Magnesium by Dr. Reddy's Laboratories, Inc.
D-0995-2019 - Discoloration
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on February 6, 2019 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-0995-2019
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
02-06-2019
02-20-2019
40,592, 90 and 1,000 count 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.
Distributed Nationwide in the USA
01-26-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.
Batch or Lot Expiration Information
Lot# : a) C800589, Exp 5/2019; C706058, Exp 03/2019
Lot# : b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
