Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Reported: July 13, 2016 Initiated: June 3, 2016 #D-1063-2016
Product Description
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 9,330 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product 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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 9,330 bottles.
Why was this product recalled? ▼
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 13, 2016. Severity: Low. Recall number: D-1063-2016.
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