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Health product recall

Lignospan Standard and Oraverse (2014-12-12)

Starting date:
December 12, 2014
Posting date:
December 23, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43053

Recalled products

A. Lignospan Standard

B. Oraverse

Reason

A partial number of boxes from lot D01028c (Lignospan Standard) / D00989c (Oraverse) are subject to the recall following exposure to sub-zero temperatures during transportation potentially resulting in a loss of sterility.

Depth of distribution

Retailers (Dental Clinics)

Affected products

A. Lignospan Standard

DIN, NPN, DIN-HIM

DIN 00375780

Dosage form

Liquid

Strength

Epinephrine 18 µg / 1.8 mL

Lidocaine Hydrochloride 36 mg / 1.8 mL

Lot or serial number

D01028c

Companies
Recalling Firm

Mediclub Dentaire Inc.

175 Montée-de-Liesse

Montreal

H4T 1T9

Quebec

CANADA

Marketing Authorization Holder

Septodont

58 Rue du Pont de Creteil

St-Maur-Des-Fosses

94107

FRANCE



B. Oraverse

DIN, NPN, DIN-HIM

DIN 02421666

Dosage form

Solution

Strength

Phentolamine Mesylate 0.4 mg / 1.7 mL

Lot or serial number

D00989c

Companies
Recalling Firm

Mediclub Dentaire Inc.

175 Montée-de-Liesse

Montreal

H4T 1T9

Quebec

CANADA

Marketing Authorization Holder

Septodont

58 Rue du Pont de Creteil

St-Maur-Des-Fosses

94107

FRANCE