FDA recall D-1256-2020

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

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

Reason for recall

Discoloration: product contains brown pellets

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2020-04-24
Report date: 2020-05-06
Termination date: 2022-05-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1256-2020