FDA recall D-0420-2018

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

Product

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

Reason for recall

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2018-01-29
Report date
2018-02-07
Termination date
2018-12-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0420-2018