Health product recall

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

Report a problem or mistake on this page
What was wrong?

If you want to receive a follow-up reply, please include your name and e-mail address.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Date modified: