SIROLIMUS Recall D-0881-2022
Description: 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
SIROLIMUS Recall D-0881-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0881-2022 |
| Event ID | 90114 |
| Brand | SIROLIMUS |
| Generic Name | SIROLIMUS |
| Manufacturer | SIROLIMUS |
| Original Package? | 1 |
| Active Substance | SIROLIMUS |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 2353 bottles |
| Recall Reason | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. |
| Drug Classification | Class III |
| Drug Code Info | 20220525 |
| Product NDC | 60505-6197 |
| Product NUI | N0000175550 N0000175625 N0000175624 |
| Pharma Class (PE) | Decreased Immunologic Activity [PE] |
| Pharma Class (EPC) | mTOR Inhibitor Immunosuppressant [EPC] |
| Recall Initiation Date | 20220503 |
| Report Date | 20220525 |
| Classification Date | 20220518 |
| Address | 2400 N Commerce Pkwy Ste 400 Weston, FL 33326-3253 United States |
| Recalling Firm | Apotex Corp. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | W36ZG6FT64 |
| Drug Application Number | ANDA211406 |
| Structured Product Labeling (SPL ID) | 0735534c-0f71-1400-5d87-fc99fc30a11d |
| Structured Product Labeling (SPL Set ID) | 9f64692d-2a18-ffcb-c572-0f218a71ca67 |
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