Medications & Supplements/Prescription Drugs

Apotex Sirolimus Oral Solution Recalled for Failed Dissolution

Agency Publication Date: May 18, 2022

Summary

Apotex Corp. is recalling approximately 2,353 bottles of Sirolimus Oral Solution (1 mg/mL) in 60 mL bottles. The recall was initiated because a specific lot failed dissolution testing, meaning the medication may not dissolve at the required rate to be effective. No incidents or injuries have been reported to date regarding this issue.

Risk

The drug failed to meet dissolution specifications during stability testing, which could prevent the medication from being properly absorbed by the body. This failure may reduce the effectiveness of the treatment for patients relying on the medication.

What You Should Do

This recall affects Sirolimus Oral Solution (1 mg/mL) sold in 60 mL bottles under NDC 60505-6197-2.
Check your medication bottle for lot number RZ1598 with an expiration date of 02/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Apotex Corp. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sirolimus Oral Solution (1 mg/mL, 60 mL bottle)

Variants: 1 mg/mL, 60 mL bottle, Rx Only

Lot Numbers:

RZ1598 (Exp 02/2023)

NDC:

60505-6197-2

Manufactured by Apotex Inc. in Toronto, Canada for Apotex Corp. in Weston, Florida.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90114

Status: Resolved

Manufacturer: Apotex Corp.

Sold By: pharmacies; healthcare providers

Manufactured In: Canada, United States

Units Affected: 2353 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Sirolimus Oral Solution (1 mg/mL) sold in 60 mL bottles under NDC 60505-6197-2.

Check your medication bottle for lot number RZ1598 with an expiration date of 02/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Apotex Corp. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.