Summary

Issue: Important Safety Information
Audience: General Public, Healthcare Professionals
Category: Drugs
Alert type: Advisory
Department: Health Canada

Details

October 9, 2021
For immediate release

Summary

• Product: Riva-Risperidone 0.25 mg tablets (DIN 02283565)
• Issue: Laboratoire Riva Inc. is recalling one lot (C9323) of Riva-Risperidone 0.25 mg tablets due to a packaging error. Some bottles may incorrectly contain only Riva-Gabapentin 100 mg capsules, which is a different prescription drug.
• What to do: If your pill bottle of Riva-Risperidone contains white capsules, or if you are unsure, return it to your pharmacy as soon as possible. Your pharmacist will check it and provide a replacement if needed. Contact your health care professional immediately if you notice that your condition or symptoms are getting worse, or if you are experiencing serious side effects.

Issue

Laboratoire Riva Inc. is recalling one lot (lot C9323) of Riva-Risperidone 0.25 mg tablets due to a packaging error. Some bottles may incorrectly contain only Riva-Gabapentin 100 mg capsules. Pharmacists may not recognize the error and inadvertently repackage and dispense pill bottles that contain the wrong medication.

Risperidone is a prescription drug used in adults to treat the symptoms of schizophrenia and related psychotic disorders, as well as bipolar disorder. It may also be used for the short-term treatment of severe dementia related to Alzheimer's disease.

Gabapentin is a prescription drug used for treating epilepsy (seizures).

If you miss a dose of Risperidone, you may not have proper control of your condition or its symptoms may worsen.

By taking Gabapentin instead of Risperidone, you may:

• develop serious side effects, such as swelling of the legs, ankles or feet (edema)
• experience side effects, such as agitation, drowsiness, dizziness, lack of muscle coordination and fatigue

If you notice any of these signs or symptoms, contact your health care professional immediately.

Riva-Risperidone 0.25 mg tablets are yellowish-orange, oblong-shaped coated tablets, with "0.25" on one side and "R" on the other side. Riva-Gabapentin 100 mg capsules are white hard gelatin capsules, with "Gabapentin / 100 mg" printed on the capsule in blue ink.

Health Canada is monitoring the company's recall. If additional safety information is identified, Health Canada will take appropriate action and inform Canadians as needed.

Affected products

What you should do

• If your pill bottle of Riva-Risperidone contains white capsules, or if you are unsure, return it to your pharmacy as soon as possible for a replacement. Your pharmacist will check it and provide a replacement if needed.
• Contact your health care professional immediately if you notice that your condition or symptoms are getting worse, or if you are experiencing serious side effects.
• Contact Laboratoire Riva Inc. by calling 1-800-363-7988 or emailing retraitrecall@labriva.com if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

Additional information for health professionals:

• Health care professionals, such as pharmacists, should check bottles of Riva-Risperidone 0.25 mg tablets before dispensing (regardless of the lot) to make sure they contain the correct pills.
• Report any unusual packages to the company and to Health Canada.

Images

Identification number

Identification number: RA-76619