What does Class III mean?

Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.

Is this recall still active?

The FDA lists the recall as terminated (closed 10/05/2023). FDA has determined the recall is complete and closed it.

Checked Oct 26, 2026

Class IIIDrug recallTerminated

Sirolimus Oral Solution recall

Recalled by Apotex Corp. of Weston, FL · FDA report 05/25/2022

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class III; Low risk
Status: Terminated; Closed 10/05/2023
Recall started: 05/03/2022
Distribution: Nationwide

Reason for recall

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Class III: Use of or exposure to the product is not likely to cause adverse health consequences.

Recalled product

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
Lot and code info: Lot: RZ1598, exp. date 02/2023
Quantity: 2353 bottles
Recall number: D-0881-2022
Event ID: 90114
Initiated by: Voluntary: Firm initiated

Where it was distributed

Nationwide in the USA

Nationwide

Recall timeline

05/03/2022Firm started the recall
05/18/2022FDA classified it as Class III
05/25/2022Published in the FDA enforcement report
10/05/2023FDA closed (terminated) the recall

More recalls from Apotex

Frequently asked questions

Why was Sirolimus Oral Solution recalled?: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
What does Class III mean?: Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.
Where was the recalled product sold?: Nationwide in the USA
Is this recall still active?: The FDA lists the recall as terminated (closed 10/05/2023). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 05/25/2022 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class III
Status: Terminated
Type: Drug
Reported: 05/25/2022

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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