Health CanadaType I

PRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine

Publié le: 30 juin 2025ID du rappel: 77659Catégorie: Produits de ConsommationPays: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

PRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine

Recalling Firm: Drugs and health products

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

Product quality

Description du produit & Identification

Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.Contact the recalling firm if you have any questions about the recall.Report any health product related side effects to Health Canada.Report any other health product safety complaints to Health Canada.

Produits concernés

PRO-Fluoxetine 10 mg capsule

Additional Source Details

FieldValue
N I D77659
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/pro-fluoxetine-10-mg-capsule-may-exceed-interim-acceptable-intake-limit-n-nitroso
IssueProduct quality
TitlePRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine
ProductPRO-Fluoxetine 10 mg capsule
Archived0
CategoryDrugs
Last updated2025-06-30
OrganizationDrugs and health products
Recall classType I
What you should doVerify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.Contact the recalling firm if you have any questions about the recall.Report any health product related side effects to Health Canada.Report any other health product safety complaints to Health Canada.

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 PRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine?

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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Aperçu

  • Entreprise responsableDrugs and health products
  • Niveau de risqueType I
Recall Hazard Severity
Caution (Class III)
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🚨 SAFETY ALERT: Drugs and health products - PRO-Fluoxetine 10 mg capsule; may exceed the interim acceptable intake limit for N-nitroso-fluoxetine

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https://therecallfile.com/fr/recalls/pro-fluoxetine-10-mg-capsule-may-exceed-the-interim-acceptable-intake/CANADA-77659
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