FDAFDA · Food and drugs·Recall number D-0881-2022
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
Published May 25, 2022 · Recall initiated: May 3, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SIROLIMUS
- Manufacturer
- Apotex Corp.
- Distributor
- Nationwide in the USA
- Lot
- Lot: RZ1598, exp. date 02/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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