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Health product recall

MINT-Risperidone

Starting date:
March 14, 2012
Posting date:
April 2, 2012
Type of communication:
Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Identification number:
RA-2012A40

Reason

During related substance analysis for stability samples, one additional unknown peak was found at around relative retention time (RRT) of 1.86 for the 0.25 mg, 0.5 mg and 1 mg tablets in bottles. The stability data for blisters of 0.25 mg, 0.5 mg and 1 mg tablets remains within specification. There were no stability failures for the 2 mg, 3 mg and/or 4 mg tablets in either bottles or blisters.

Depth of distribution

Wholesalers and retailers (pharmacies) across Canada.

Affected products

MINT-Risperidone

DIN, NPN, DIN-HIM

0.25mg tab - DIN 02359790 0.5mg tabs - DIN 02359804 1 mg tabs - DIN 02359812 2 mg tabs - DIN 02359820 3 mg tabs - DIN 02359839 4 mg tabs - DIN 02359847

Dosage form

Tablet

Strength

0.25 mg tablets 0.5 mg tablets 1 mg tablets 2 mg tablets 3 mg tablets 4 mg tablets

Lot or serial number

0.25mg tabs - 100 Bottle - E0B021001 - exp2013-01-31 0.25mg tabs - 100 Bottle - E0B021002 - exp2013-01-31 0.5mg tabs - 100 Bottle - E0C1001F - exp2013-01-31 0.5mg tabs - 100 Bottle - E0C1002F - exp2013-01-31 1mg tabs - 100 Bottle - E0D1001F - exp2013-01-31 1mg tabs - 100 Bottle - E0D1002F - exp2013-01-31 2 mg tabs - 100 Bottle - E0E1001F - exp2013-01-31 3 mg tabs - 100 Bottle - E0F1001F - exp2013-06-30 3 mg tabs - 100 Bottle - E0F0310002 - exp2013-06-30 4 mg tabs - 100 Bottle - E0G1001F - exp2013-01-31 0.25 mg tabs - 60 Blister - E0B1001F - exp2013-01-31 0.5 mg tabs - 60 Blister - E0C1001F - exp2013-01-31 1 mg tablets - 60 Blister - E0D1001F - exp2013-01-31 2 mg tablets - 60 Blister - E0E1001F - exp2013-01-31 3 mg tablets - 60 Blister - E0F1001F - exp2013-01-31 4 mg tablets - 60 Blister - E0G1001F - exp2013-01-31

Companies

Recalling Firm
Mint Pharmaceuticals Inc. 1093 Meyerside Drive, Unit #1 Mississauga, ON L5T 1J6
Marketing Authorization Holder
IPCA Laboratories Limited Plot No. 255/1, Village Athal, Silvassa, Dadra and Nagar Haveli, India 396230

Date modified: