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Health product recall

MINT-LEVOCARB (2017-12-13)

Starting date:
December 13, 2017
Posting date:
December 13, 2017
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-65868

Affected Products

  1. MINT-LEVOCARB 10/100mg (Carbidopa 10mg, Levopdoba 100mg)
  2. MINT-LEVOCARB  25/100mg (Carbidopa 25mg, Levodopa 100mg)
  3. MINT-LEVOCARB 25/250mg (Carbidopa 25mg, Levodopa 250mg)

Reason

Potential product quality concerns as a result of deficiencies in Good Manufacturing Practices (GMP) at the finished product manufacturer.

Depth of distribution

Wholesalers

Affected products

A. MINT-LEVOCARB 10/100mg (Carbidopa 10mg, Levopdoba 100mg)

DIN, NPN, DIN-HIM
DIN 02457954
Dosage form

Tablet

Strength

Carbidopa 10mg, Levodopa 100mg

Lot or serial number

All Lots

Companies
Recalling Firm
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA
Marketing Authorization Holder
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA

B. MINT-LEVOCARB  25/100mg (Carbidopa 25mg, Levodopa 100mg)

DIN, NPN, DIN-HIM
DIN 02457962
Dosage form

Tablet

Strength

Carbidopa 25mg, Levodopa 100mg

Lot or serial number

All lots

Companies
Recalling Firm
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA
Marketing Authorization Holder
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA

C. MINT-LEVOCARB 25/250mg (Carbidopa 25mg, Levodopa 250mg)

DIN, NPN, DIN-HIM
DIN 02457970
Dosage form

Tablet

Strength

Carbidopa 25mg, Levodopa 250mg

Lot or serial number

All lots

Companies
Recalling Firm
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA
Marketing Authorization Holder
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA

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