Recall: D-1063-2016

Class III - Minor Violations

Class IIIClassification

2016-06-03Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.