FDA recall D-1063-2016

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

Product

Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

Reason for recall

Failed impurities/degradation: out of specification result for impurity secorapamycin.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-06-03
Report date: 2016-07-13
Termination date: 2017-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2016