FDA recall D-1373-2015

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

Product

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Distribution

U.S. Nationwide

Key facts

Status: Terminated
Initiation date: 2015-08-13
Report date: 2015-09-02
Termination date: 2016-12-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1373-2015