Drug recall D-0881-2022

Class III Terminated reported May 25, 2022

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.

Lots and codes

Lot: RZ1598, exp. date 02/2023

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
2353 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 3, 2022
Terminated
October 5, 2023

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