Home / Recalls / Apotex Corp. / D-0881-2022

D-0881-2022 Class III Terminated

Recalled by Apotex Corp. — Weston, FL

Recall Details

Product Type: Drugs
Report Date: May 25, 2022
Initiation Date: May 3, 2022
Termination Date: October 5, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2353 bottles

Product 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

Reason for Recall

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: RZ1598, exp. date 02/2023

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