FDA Drug recall D-0813-2021
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columb…
- FDA Drug
- Class III
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class III recall of Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columb… by American Health Packaging, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0813-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-05-12 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Health Packaging |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 68084-915-95 |
|---|---|
| ndc | 68084-915-25 |
| code_info | Lot #: 1000789, Exp. Date 10/31/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0813-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.