Reported May 25, 2022 · Terminated
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9…
Apotex Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253
Is this the product you have?
- Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only
- Manufactured byApotex Inc. Toronto
- Ontario Canada M9L 1T9 Manufactured for
Apotex Corp. WestonFlorida 33326NDC 60505-6197-2
- Lot codes and dates
- Lot
RZ1598exp. date 02/2023
- Lot
- Amount recalled
- 2353 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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