Class III
Terminated
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
- Company
- Apotex Corp.
- Recall Initiated
- May 3, 2022
- Posted
- May 25, 2022
- Recall Number
- D-0881-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2353 bottles
- Firm Location
- Weston, FL, United States
Reason for Recall
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Distribution
Nationwide in the USA
Lot / Code Info
Lot: RZ1598, exp. date 02/2023
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