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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