Health CanadaType I
Auro Pharma Losartan product recall (2021-10-12)
Published: October 12, 2021Recall ID: RA-76627Category: generalCountry: Canada
Safety AlertHealth CanadaCanada
CanadaAuro Pharma Losartan product recall (2021-10-12)
Product Description & Identification
Auro Pharma Losartan product recall (2021-10-12)
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. Auro-Losartan HCT 50mg/12.5mg B. Auro-Losartan HCT 100mg/12.5mg C. Auro-Losartan HCT 100mg/25mg<BR/> |
| Panels › 2 › Title | Summary |
| Panels › 2 › Panel Name | summary |
| Panels › 3 › Text | <p> A. Auro-Losartan HCT 50mg/12.5mg</p> <p> B. Auro-Losartan HCT 100mg/12.5mg</p> <p> C. Auro-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 | Wholesalers, Retailers, Healthcare Establishments |
| Panels › 5 › Title | Depth of distribution |
| Panels › 5 › Panel Name | cms_reason_depth_distribution |
| Panels › 6 › Text | <b>Brand name:</b> Auro-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 02423642<BR/><b>Lot or serial number:</b> ACI5021007B, QX5019009-C, QX5019010-A, QX5019011-B, QX5019009-B<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Auro Pharma Inc.</dd><dd>3700 Steeles Ave. W</dd><dd>Woodbridge</dd><dd>L4L 8K8</dd><dd>Ontario</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Auro Pharma Inc.</dd><dd>3700 Steeles Ave. W</dd><dd>Woodbridge</dd><dd>L4L 8K8</dd><dd>Ontario</dd><dd>CANADA</dd></dl> |
| Panels › 6 › Title | Auro-Losartan HCT 50mg/12.5mg |
| Panels › 6 › Panel Name | product_1 |
| Panels › 7 › Text | <b>Brand name:</b> Auro-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 02423650<BR/><b>Lot or serial number:</b> ACO1021003A, QY1018012-B, QY1018013-A, QY1018014-A, QY1018015-A, QY1019009-D, QY1018010-A, QY1018011-A, QY1018012-A, QY1019009-A<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Auro Pharma Inc.</dd><dd>3700 Steeles Ave. W</dd><dd>Woodbridge</dd><dd>L4L 8K8</dd><dd>Ontario</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Auro Pharma Inc.</dd><dd>3700 Steeles Ave. W</dd><dd>Woodbridge</dd><dd>L4L 8K8</dd><dd>Ontario</dd><dd>CANADA</dd></dl> |
| Panels › 7 › Title | Auro-Losartan HCT 100mg/12.5mg |
| Panels › 7 › Panel Name | product_2 |
| Panels › 8 › Text | <b>Brand name:</b> Auro-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 02423669<BR/><b>Lot or serial number:</b> ACI1021007A, QX1019011-A, QX1019010-B, QX1019008-A, QX1019009-B, QX1019007-A<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Auro Pharma Inc.</dd><dd>3700 Steeles Ave. W</dd><dd>Woodbridge</dd><dd>L4L 8K8</dd><dd>Ontario</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Auro Pharma Inc.</dd><dd>3700 Steeles Ave. W</dd><dd>Woodbridge</dd><dd>L4L 8K8</dd><dd>Ontario</dd><dd>CANADA</dd></dl> |
| Panels › 8 › Title | Auro-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-76627<BR/> |
| Panels › 10 › Title | Identification number |
| Panels › 10 › Panel Name | id_numbers |
| Recall Id | RA-76627 |
| Start date | 1633996800 |
| Date published | -62169984000 |
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