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Health CanadaGeneral Alert

Recall: One lot of Riva-Risperidone 0.25 mg tablets recalled due to a packaging error

Publié le: 9 octobre 2021ID du rappel: RA-76619Catégorie: Produits de ConsommationPays: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

Recall: One lot of Riva-Risperidone 0.25 mg tablets recalled due to a packaging error

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Description du produit & Identification

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 Company Product DIN Lot # Expiration Date Laboratoire Riva Inc. Riva-Risperidone 0.25 mg tablets 100-tablet bottles 02283565 C9323 2022-MR-31 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 .

Additional Source Details

FieldValue
Panels › 1 › Text<b>Issue:</b> Important Safety Information<BR/><b>Audience:</b> General Public, Healthcare Professionals<BR/><b>Category:</b> Drugs<BR/><b>Alert type:</b> Advisory<BR/><b>Department:</b> Health Canada<BR/>
Panels › 1 › TitleSummary
Panels › 1 › Panel Namebasic_details
Panels › 2 › Text<p> <strong>October 9, 2021</strong><br /> <strong>For immediate release</strong></p> <h2> Summary</h2> <ul> <li> <strong>Product:</strong> Riva-Risperidone 0.25 mg tablets (DIN 02283565)</li> <li> <strong>Issue:</strong> 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.</li> <li> <strong>What to do:</strong> 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.</li> </ul> <h2> Issue</h2> <p> 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.</p> <p> 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.</p> <p> Gabapentin is a prescription drug used for treating epilepsy (seizures).</p> <p> If you miss a dose of Risperidone, you may not have proper control of your condition or its symptoms may worsen.</p> <p> By taking Gabapentin instead of Risperidone, you may:</p> <ul> <li> develop serious side effects, such as swelling of the legs, ankles or feet (edema)</li> <li> experience side effects, such as agitation, drowsiness, dizziness, lack of muscle coordination and fatigue</li> </ul> <p> If you notice any of these signs or symptoms, contact your health care professional immediately.</p> <p> 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.</p> <p> 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.</p> <h2> Affected products</h2> <p> <class> </class></p> <table> <tbody> <tr> <th scope="col"> <p> <strong>Company</strong></p> </th> <th scope="col"> <p> <strong>Product</strong></p> </th> <th scope="col"> <p> <strong>DIN</strong></p> </th> <th scope="col"> <p> <strong>Lot #</strong></p> </th> <th scope="col"> <p> <strong>Expiration Date</strong></p> </th> </tr> <tr> <td> <p> Laboratoire Riva Inc.</p> </td> <td nowrap="nowrap"> <p> Riva-Risperidone 0.25 mg tablets<br /> 100-tablet bottles</p> </td> <td> <p> 02283565</p> </td> <td> <p> C9323</p> </td> <td nowrap="nowrap"> <p> 2022-MR-31</p> </td> </tr> </tbody> </table> <h2> <strong>What you should do</strong></h2> <ul> <li> 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.</li> <li> 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.</li> <li> Contact Laboratoire Riva Inc. by calling 1-800-363-7988 or emailing <a href="mailto:retraitrecall@labriva.com">retraitrecall@labriva.com</a> if you have questions about the recall.</li> <li> Report any health product-related <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html">side effects</a> or <a href="https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html">complaints</a> to Health Canada.</li> </ul> <h3> <strong>Additional information for health professionals:</strong></h3> <ul> <li> 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.</li> <li> Report any unusual packages to the company and to <a href="http://healthycanadians.gc.ca/apps/radar/MD-IM-0005.08.html">Health Canada</a>.</li> </ul>
Panels › 2 › TitleDetails
Panels › 2 › Panel Namedetails
Panels › 3 › Data › 1 › TitleRiva-Gabapentin 100 mg capsules (white hard gelatin capsules, with “Gabapentin / 100 mg” printed on the capsule in blue ink)
Panels › 3 › Data › 1 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/Photo_capsule_Gabapentin_100mg_s_fs_null_20211009-173330_13_en.jpg
Panels › 3 › Data › 1 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/Photo_capsule_Gabapentin_100mg_s_m_null_20211009-173330_13_en.jpg
Panels › 3 › Data › 2 › TitleRiva-Risperidone 0.25 mg tablets (yellowish-orange, oblong-shaped coated tablets, with “0.25” on one side and “R” on the other side)
Panels › 3 › Data › 2 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/Photo_comprimé_Risperidone_025mg_s_fs_null_20211009-173353_20_en.jpg
Panels › 3 › Data › 2 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/Photo_comprimé_Risperidone_025mg_s_m_null_20211009-173353_20_en.jpg
Panels › 3 › Data › 3 › TitleRiva-Risperidone 0.25 mg bottle that incorrectly contains only Riva-Gabapentin 100 mg capsules
Panels › 3 › Data › 3 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/RivaRisperidone_bottleofincorrectcapsules_s_fs_null_20211009-173414_11_en.png
Panels › 3 › Data › 3 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/RivaRisperidone_bottleofincorrectcapsules_s_m_null_20211009-173414_11_en.png
Panels › 3 › TitleImages
Panels › 3 › Panel Nameimages
Panels › 4 › Text<b>Identification number:</b> RA-76619<BR/>
Panels › 4 › TitleIdentification number
Panels › 4 › Panel Nameid_numbers
Recall IdRA-76619
Start date1633737600
Date published-62169984000

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Recall: One lot of Riva-Risperidone 0.25 mg tablets recalled due to a packaging error?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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