Drug recall D-0995-2019

Class III Terminated reported Feb 20, 2019

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.

Reason for recall

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

Lots and codes

Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
40,592, 90 and 1,000 count bottles
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 6, 2019
Terminated
January 26, 2021

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