D-0881-2022 Class III Terminated
FDA drug recall D-0881-2022 was initiated by Apotex Corp. on May 3, 2022 and is designated Class III. Reason for recall: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. The recall status is terminated (terminated Oct 5, 2023). Affected quantity: 2353 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 25, 2022
- Initiation Date
- May 3, 2022
- Termination Date
- Oct 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2353 bottles
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.
Distribution pattern
Nationwide in the USA
Code information
Lot: RZ1598, exp. date 02/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0881-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026