FDA recall D-0995-2019

Dr. Reddy's Laboratories, Inc. · Class III · drug

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.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2019-02-06
Report date: 2019-02-20
Termination date: 2021-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0995-2019