Sirolimus Tablets 1 mg — Class III drug recall D-0813-2021
Terminated recall by American Health Packaging, reported 2021-09-29, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0813-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2021-05-12 |
| Classified | 2021-09-20 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2022-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 290 cartons |
| Reason classes | specification failure |
| NDC | 68084-0915, 68084-0915-25, 68084-0915-95 |
| Lot numbers | 1000789 |
| Expiration dates | 2022-10-31 |
Product
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0813-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.