FDA recall D-1146-2015

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

Product

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India

Reason for recall

Subpotent drug

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-05-06
Report date: 2015-06-24
Termination date: 2016-03-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1146-2015