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PMS-Enalapril Product Recall (2015-04-29)
- Starting date:
- April 29, 2015
- Posting date:
- May 7, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53323
Recalled products
- PMS-Enalapril 4 mg
- PMS-Enalapril 8 mg
Reason
During routine stability testing, the product did not meet degradation product specifications.
Depth of distribution
Wholesalers and Retailers
Affected products
A. PMS-Enalapril 4 mg
DIN, NPN, DIN-HIM
DIN 02300087
Dosage form
Tablet
Strength
- Enalapril sodium 4 mg
Lot or serial number
- 479754
Companies
- Recalling Firm
-
Pharmascience
100, 6111 Royalmount,
Montreal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience
100, 6111 Royalmount,
Montreal
H4P 2T4
Quebec
CANADA
B. PMS-Enalapril 8 mg
DIN, NPN, DIN-HIM
DIN 02300095
Dosage form
Tablet
Strength
- Enalapril sodium 8 mg
Lot or serial number
- 468775
Companies
- Recalling Firm
-
Pharmascience
100, 6111 Royalmount,
Montreal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience
100, 6111 Royalmount,
Montreal
H4P 2T4
Quebec
CANADA