Recalls / Class III
Class IIID-0881-2022
Product
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
- Brand name
- Sirolimus
- Generic name
- Sirolimus
- Active ingredient
- Sirolimus
- Route
- Oral
- NDC
- 60505-6197
- FDA application
- ANDA211406
- Affected lot / code info
- Lot: RZ1598, exp. date 02/2023
Why it was recalled
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Recalling firm
- Firm
- Apotex Corp.
- Manufacturer
- Apotex Corp
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 2353 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-05-03
- FDA classified
- 2022-05-18
- Posted by FDA
- 2022-05-25
- Terminated
- 2023-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0881-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.