Sirolimus Oral Solution — Class III drug recall D-0881-2022
Terminated recall by Apotex Corp., reported 2022-05-25, distributed nationwide. Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specificati
| Recall number | D-0881-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2022-05-03 |
| Classified | 2022-05-18 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2023-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 2,353 bottles |
| Reason classes | specification failure |
| NDC | 60505-6197-02 |
| Lot numbers | RZ1598 |
| Expiration dates | 2023-02 |
Product
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
Reason for recall
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
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-0881-2022. 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.