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Riva-Pravastatin
- Starting date:
- April 5, 2013
- Posting date:
- April 23, 2013
- 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-26849
Recalled Products
- Riva-Pravastatin
Reason
Stability tests revealed an increase in Pravastatin Lactone impurities above the acceptable limit (2.0% before the product's best before date of 24 months).
Depth of distribution
Wholesalers and pharmacies in Canada.
Affected products
A. Riva-Pravastatin
DIN, NPN, DIN-HIM
DIN 02270234
Dosage form
- Tablet
Strength
- Pravastatin Sodium 10 mg
Lot or serial number
- P3572
Companies
- Recalling Firm
-
Laboratoire Riva Inc.
660 Industrial Blvd.
Blainville
J7C 3V4
Quebec
CANADA
- Marketing Authorization Holder
-
Laboratoire Riva Inc.
660 Industrial Blvd.
Blainville
J7C 3V4
Quebec
CANADA