Health CanadaType I
Sivem Pharmaceuticals Losartan HCT product recall (2021-10-13)
Published: October 13, 2021Recall ID: RA-76643Category: generalCountry: Canada
Safety AlertHealth CanadaCanada
CanadaSivem Pharmaceuticals Losartan HCT product recall (2021-10-13)
Product Description & Identification
Sivem 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 |
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