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
Reported: May 25, 2022 Initiated: May 3, 2022 #D-0881-2022
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.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 2353 bottles
- Distribution
- Nationwide in the USA
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Corp.. Units affected: 2353 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2022. Severity: Low. Recall number: D-0881-2022.
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