PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: February 20, 2019 Initiated: February 6, 2019 #D-0995-2019

Product Description

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.

Details

Units Affected
40,592, 90 and 1,000 count bottles
Distribution
Distributed Nationwide in the USA
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 40,592, 90 and 1,000 count bottles.
Why was this product recalled?
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 20, 2019. Severity: Low. Recall number: D-0995-2019.