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Dr. Reddy's Laboratories, Inc. recalls Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5

Recalled July 13, 2016 · FDA recall D-1063-2016 · Dr. Reddy's Laboratories

Hazard
Failed impurities/degradation: out of specification result for impurity secorapamycin. · FDA Class III
Units
9,330 bottles
Sold at
Nationwide

Description

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

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Dr. Reddy's Laboratories, Inc. recalls Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5 | RecallWatchUSA