FDA recall D-1378-2015

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

Product

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

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-1378-2015