FDA-Drug2022-05-25Class III
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
Apotex Corp.
Hazard
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Sold states
Nationwide in the USA
Affected count
2353 bottles
Manufactured in
2400 N Commerce Pkwy Ste 400, N/A, Weston, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0881-2022Don't want to check this manually?
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