OraVerse Injection (2018-04-20)
- Starting date:
- April 20, 2018
- Posting date:
- April 27, 2018
- 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-66664
Affected Products
OraVerse Injection
Reason
Out of specification for phentolamine mesylate assay in lot D01894D. Out of trend for degradation product impurity (phentolamide) in lots D01894D and D01894F.
Depth of distribution
Wholesalers in ON, QC, AB and BC
Affected products
OraVerse Injection
DIN, NPN, DIN-HIM
DIN 02421666
Dosage form
Powder for solution
Strength
phentolamine mesylate Injection 0.4 mg/1.7 mL
Lot or serial number
- D01894D
- D01894F
Companies
- Recalling Firm
-
N/A
- Marketing Authorization Holder
-
SEPTODONT
58 Rue Du Pont De Creteil, St-Maur-Des-Fosses, Val-De-Marne, France