Dr. Reddy's Laboratories, Inc. recalls Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam -…
- Recall date
- June 3, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1063-2016
- FDA classification
- Class III
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
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