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Class III: unlikely to cause harmTerminated

Apotex Risperidone Oral Solution Recall

Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc

Apotex Inc.

Risk level
Class III
Reported by FDA
May 7, 2014
Recall ID
D-1299-2014
Check your lot numberHow we source this data

Summary

Apotex recalled Risperidone Oral Solution starting Mar 20, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1299-2014 on May 7, 2014. Reason: Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

Product description

Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.

Lot numbers, UPCs & expiration codes

Lot #: KD4855, Exp 06/14

Where it was sold

Nationwide and Puerto Rico.

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-1299-2014
Classification
Class III
Status
Terminated
Recall initiated
Mar 20, 2014
FDA report date
May 7, 2014
Quantity
11,422 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Apotex Inc.

Original FDA data

Every field from FDA enforcement report D-1299-2014, exactly as published.

Show all FDA fields
City
Toronto
Status
Terminated
Country
Canada
Event ID
67985
Address
150 Signet Drive
Code information
Lot #: KD4855, Exp 06/14
Report date
May 7, 2014
Product type
Drugs
Recall number
D-1299-2014
Classification
Class III
Recalling firm
Apotex Inc.
Product quantity
11,422 bottles
Termination date
Dec 23, 2014
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
Distribution pattern
Nationwide and Puerto Rico.
Recall initiation date
Mar 20, 2014
Initial firm notification
Letter
Center classification date
May 1, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1299-2014, published May 7, 2014. 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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