FDA recall D-0886-2018

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

Product

Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status
Terminated
Initiation date
2018-06-12
Report date
2018-06-27
Termination date
2019-11-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0886-2018