COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
CanadaCOMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
Recalling Firm: Marketed health products
Motivo del Retiro / Peligro
TranslatedLabelling - Packaging - Product safety - Supply - COVID
Descripción del Producto e Identificación
TranslatedCOMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
Productos Afectados
TranslatedCOMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine
Additional Source Details
| Field | Value |
|---|---|
| N I D | 72341 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/comirnaty-original-omicron-ba4ba5-bivalent-vaccine-english-only-vial-and-carton-0 |
| Issue | Labelling - Packaging - Product safety - Supply - COVID |
| Title | COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age |
| Product | COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine |
| Archived | 0 |
| Category | Biologic or vaccine |
| Last updated | 2022-12-09 |
| Organization | Marketed health products |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
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 GuideQ1:What should I do immediately if I own or bought COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for...?
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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Resumen
- Empresa ResponsableMarketed health products
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🚨 SAFETY ALERT: Marketed health products - COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age Check if your household is affected: https://therecallfile.com/es/recalls/comirnaty-original-omicron-ba-4-ba-5-bivalent-vaccine-with-english-onl/CANADA-72341
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