Sivem Pharmaceuticals Losartan HCT product recall (2021-10-13)
CanadaSivem Pharmaceuticals Losartan HCT product recall (2021-10-13)
Descripción del Producto e Identificación
TranslatedSivem Pharmaceuticals Losartan HCT product recall (2021-10-13)
Additional Source Details
| Field | Value |
|---|---|
| Panels › 1 › Text | <b>Issue:</b> Product Safety<BR/><b>Audience:</b> General Public, Healthcare Professionals, Hospitals<BR/><b>Category:</b> Drugs<BR/><b>Alert type:</b> Drug Recall<BR/><b>Department:</b> Health Canada<BR/><b>Hazard classification:</b> Type I<BR/> |
| Panels › 1 › Title | Summary |
| Panels › 1 › Panel Name | basic_details |
| Panels › 2 › Text | <b>Product: </b>A. Losartan HCT 50mg/12.5mg B. Losartan HCT 100mg/12.5mg C. Losartan HCT 100mg/25mg<BR/> |
| Panels › 2 › Title | Summary |
| Panels › 2 › Panel Name | summary |
| Panels › 3 › Text | <p> A. Losartan HCT 50mg/12.5mg</p> <p> B. Losartan HCT 100mg/12.5mg</p> <p> C. Losartan HCT 100mg/25mg</p> |
| Panels › 3 › Title | Introduction |
| Panels › 3 › Panel Name | intro_text |
| Panels › 4 › Text | Presence of impurity (5-[4'-[(5-(Azidomethyl)-2-butyl-4-chloro-1H-imidazol-1-yl)methyl]-[1,1'-biphenyl]-2-yl]-1H-tetrazole) above the acceptable concentration limit in affected lots |
| Panels › 4 › Title | Reason |
| Panels › 4 › Panel Name | cms_reason_reason_recall |
| Panels › 5 › Text | Retailers |
| Panels › 5 › Title | Depth of distribution |
| Panels › 5 › Panel Name | cms_reason_depth_distribution |
| Panels › 6 › Text | <b>Brand name:</b> Losartan HCT 50mg/12.5mg<br/><b>Dosage form:</b> Tablet<BR/><b>Strength:</b> Losartan Potassium 50mg Hydrochlorothiazide 12.5mg<BR/><b>DIN, NPN, DIN-HIM:</b> DIN 02388960<BR/><b>Lot or serial number:</b> QX5019001-A,QX5019002-A,QX5019003-A,QX5019008-A,QX5019007-A,QX5019005-A,QX5019006-A,QX5019004-A,QX5019010B,ACI5021007A,ACI5021005A,ACI5021006A,ACI5021004B,QX5019009-A,QX5019011-A,ACI5021004A<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Sivem Pharmaceuticals ULC</dd><dd>4705 Dobrin Street </dd><dd>Saint-Laurent</dd><dd>H4R 2P7</dd><dd>Quebec</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Sivem Pharmaceuticals ULC</dd><dd>4705 Dobrin Street </dd><dd>Saint-Laurent</dd><dd>H4R 2P7</dd><dd>Quebec</dd><dd>CANADA</dd></dl> |
| Panels › 6 › Title | Losartan HCT 50mg/12.5mg |
| Panels › 6 › Panel Name | product_1 |
| Panels › 7 › Text | <b>Brand name:</b> Losartan HCT 100mg/12.5mg<br/><b>Dosage form:</b> Tablet <BR/><b>Strength:</b> Losartan Potassium 100mg Hydrochlorothiazide 12.5mg<BR/><b>DIN, NPN, DIN-HIM:</b> DIN 02388979<BR/><b>Lot or serial number:</b> QY1019002-A,QY1019001-A,QY1019003-A,QY1019004-A,QY1019008A,QY1019007B,QY1019009C,ACO1021003AR,ACO1021001B,ACO1021002A,QY1019005-A,QY1019006-A,QY1019007-A,QY1019009-B,ACO1021001A<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Sivem Pharmaceuticals ULC</dd><dd>4705 Dobrin Street </dd><dd>Saint-Laurent</dd><dd>H4R 2P7</dd><dd>Quebec</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Sivem Pharmaceuticals ULC</dd><dd>4705 Dobrin Street </dd><dd>Saint-Laurent</dd><dd>H4R 2P7</dd><dd>Quebec</dd><dd>CANADA</dd></dl> |
| Panels › 7 › Title | Losartan HCT 100mg/12.5mg |
| Panels › 7 › Panel Name | product_2 |
| Panels › 8 › Text | <b>Brand name:</b> Losartan HCT 100mg/25mg<br/><b>Dosage form:</b> Tablet <BR/><b>Strength:</b> Losartan Potassium 100mg Hydrochlorothiazide 25mg<BR/><b>DIN, NPN, DIN-HIM:</b> DIN 02388987<BR/><b>Lot or serial number:</b> QX1019001A,QX1019002A,QX1019005A,QX1019004A,QX1019003A,QX1019003A,QX1019009C,ACI1021005B,ACI1021006A,ACI1021006A,ACI1021006A,ACI1021006A,ACI1021004A<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Sivem Pharmaceuticals ULC</dd><dd>4705 Dobrin Street </dd><dd>Saint-Laurent</dd><dd>H4R 2P7</dd><dd>Quebec</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Sivem Pharmaceuticals ULC</dd><dd>4705 Dobrin Street </dd><dd>Saint-Laurent</dd><dd>H4R 2P7</dd><dd>Quebec</dd><dd>CANADA</dd></dl> |
| Panels › 8 › Title | Losartan HCT 100mg/25mg |
| Panels › 8 › Panel Name | product_3 |
| Panels › 9 › Text | <a href="https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75715a-eng.php">https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75715a-eng.php</a> |
| Panels › 9 › Title | For more information |
| Panels › 9 › Panel Name | more_information |
| Panels › 10 › Text | <b>Identification number:</b> RA-76643<BR/> |
| Panels › 10 › Title | Identification number |
| Panels › 10 › Panel Name | id_numbers |
| Recall Id | RA-76643 |
| Start date | 1634083200 |
| Date published | -62169984000 |
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 Sivem Pharmaceuticals Losartan HCT product recall (2021-10-13)?
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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🚨 SAFETY ALERT: Sivem Pharmaceuticals Losartan HCT product recall (2021-10-13) Check if your household is affected: https://therecallfile.com/es/recalls/sivem-pharmaceuticals-losartan-hct-product-recall-2021-10-13/CANADA-RA-76643
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