FDA Drug recall D-1063-2016
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 5…
- FDA Drug
- Class III
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class III recall of Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 5… by Dr Reddy S Laboratories, citing failed impurities/degradation: out of specification result for impurity secorapamycin.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1063-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-03 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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.
Identifiers
| ndc | 55111-653-30 |
|---|---|
| ndc | 55111-653-01 |
| ndc | 55111-654-30 |
| ndc | 55111-654-01 |
| code_info | Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1063-2016%22
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