Health CanadaType I
Mint Pharmaceuticals Mint-Losartan/HCTZ product recall (2021-10-25)
Published: October 25, 2021Recall ID: RA-76745Category: generalCountry: Canada
Safety AlertHealth CanadaCanada
CanadaMint Pharmaceuticals Mint-Losartan/HCTZ product recall (2021-10-25)
Product Description & Identification
Mint Pharmaceuticals Mint-Losartan/HCTZ product recall (2021-10-25)
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. Mint-Losartan/HCTZ 50mg/12.5mg B. Mint-Losartan/HCTZ 100mg/12.5mg C. Mint-Losartan/HCTZ 100mg/25mg<BR/> |
| Panels › 2 › Title | Summary |
| Panels › 2 › Panel Name | summary |
| Panels › 3 › Text | <p> A. Mint-Losartan/HCTZ 50mg/12.5mg</p> <p> B. Mint-Losartan/HCTZ 100mg/12.5mg</p> <p> C. Mint-Losartan/HCTZ 100mg/25mg</p> |
| Panels › 3 › Title | Introduction |
| Panels › 3 › Panel Name | intro_text |
| Panels › 4 › Text | Presence of impurity Losartan Azide ((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, Wholesalers |
| Panels › 5 › Title | Depth of distribution |
| Panels › 5 › Panel Name | cms_reason_depth_distribution |
| Panels › 6 › Text | <b>Brand name:</b> A. Mint-Losartan/HCTZ 50mg/12.5mg<br/><b>Dosage form:</b> Tablet <BR/><b>Strength:</b> Losartan 50mg Hydrochlorohiazide 12.5mg<BR/><b>DIN, NPN, DIN-HIM:</b> DIN 02389657<BR/><b>Lot or serial number:</b> 2005006959, 2005006960, 2005006961, 2005006962, 2005006963, 2005011154, 2005011156<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Mint Pharmaceuticals Inc</dd><dd>6575 Davand Drive</dd><dd>Mississauga</dd><dd>L5T 2M3</dd><dd>Ontario</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Mint Pharmaceuticals Inc</dd><dd>6575 Davand Drive</dd><dd>Mississauga</dd><dd>L5T 2M3</dd><dd>Ontario</dd><dd>CANADA</dd></dl> |
| Panels › 6 › Title | A. Mint-Losartan/HCTZ 50mg/12.5mg |
| Panels › 6 › Panel Name | product_1 |
| Panels › 7 › Text | <b>Brand name:</b> B. Mint-Losartan/HCTZ 100mg/12.5mg<br/><b>Dosage form:</b> Tablet <BR/><b>Strength:</b> Losartan 100mg Hydrochlorohiazide 12.5mg<BR/><b>DIN, NPN, DIN-HIM:</b> DIN 02389665<BR/><b>Lot or serial number:</b> 2005006807, 2005006808, 2005006809, 2005006810, 2105002149<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Mint Pharmaceuticals Inc</dd><dd>6575 Davand Drive</dd><dd>Mississauga</dd><dd>L5T 2M3</dd><dd>Ontario</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Mint Pharmaceuticals Inc</dd><dd>6575 Davand Drive</dd><dd>Mississauga</dd><dd>L5T 2M3</dd><dd>Ontario</dd><dd>CANADA</dd></dl> |
| Panels › 7 › Title | B. Mint-Losartan/HCTZ 100mg/12.5mg |
| Panels › 7 › Panel Name | product_2 |
| Panels › 8 › Text | <b>Brand name:</b> C. Mint-Losartan/HCTZ 100mg/25mg<br/><b>Dosage form:</b> Tablet <BR/><b>Strength:</b> Losartan 100mg Hydrochlorohiazide 25mg<BR/><b>DIN, NPN, DIN-HIM:</b> DIN 02389673<BR/><b>Lot or serial number:</b> 1805012687, 1805012688, 1805012689, 1805012792, 1905001010, 1905001011, 2005006947, 2005006949, 2005006950, 2005006951, 2005007297, 2005007298, 2005013776, 2105002150<BR/><b>Companies:</b><br/><dl><dt>Recalling Firm</dt><dd>Mint Pharmaceuticals Inc</dd><dd>6575 Davand Drive</dd><dd>Mississauga</dd><dd>L5T 2M3</dd><dd>Ontario</dd><dd>CANADA</dd></dl><dl><dt>Marketing Authorization Holder</dt><dd>Mint Pharmaceuticals Inc</dd><dd>6575 Davand Drive</dd><dd>Mississauga</dd><dd>L5T 2M3</dd><dd>Ontario</dd><dd>CANADA</dd></dl> |
| Panels › 8 › Title | C. Mint-Losartan/HCTZ 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-76745<BR/> |
| Panels › 10 › Title | Identification number |
| Panels › 10 › Panel Name | id_numbers |
| Recall Id | RA-76745 |
| Start date | 1635120000 |
| Date published | -62169984000 |
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