FDA recall D-0727-2018

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

Product

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01

Reason for recall

Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2018-04-23
Report date
2018-05-16
Termination date
2020-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0727-2018