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Class III: unlikely to cause harmTerminated

Apotex Sirolimus Oral Solution Recall

Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc

Apotex Corp. · Weston, FL

Risk level
Class III
Reported by FDA
May 25, 2022
Recall ID
D-0881-2022
Check your lot numberHow we source this data

Summary

Apotex recalled Sirolimus Oral Solution starting May 3, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0881-2022 on May 25, 2022. Reason: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot: RZ1598, exp. date 02/2023

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0881-2022
Classification
Class III
Status
Terminated
Recall initiated
May 3, 2022
FDA report date
May 25, 2022
Quantity
2353 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Apotex Corp.

Original FDA data

Every field from FDA enforcement report D-0881-2022, exactly as published.

Show all FDA fields
City
Weston
State
FL
Status
Terminated
Country
United States
Event ID
90114
Address
2400 N Commerce Pkwy Ste 400
Code information
Lot: RZ1598, exp. date 02/2023
Postal code
33326-3253
Report date
May 25, 2022
Product type
Drugs
Recall number
D-0881-2022
Classification
Class III
Recalling firm
Apotex Corp.
Product quantity
2353 bottles
Termination date
Oct 5, 2023
Reason for recall
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the USA
Recall initiation date
May 3, 2022
Initial firm notification
Letter
Center classification date
May 18, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0881-2022, published May 25, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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