FDA recall D-0881-2022

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-05-03

Report date

2022-05-25

Termination date

2023-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0881-2022