Drug 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
D-0881-2022
Product summary
- Firm
- Apotex Corp.
- Event
- Event 90114
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2353 bottles
- Official record key
drug-enforcement:D-0881-2022
Official wording
Reason: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Code information: Lot: RZ1598, exp. date 02/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications