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Lidocaine 2% and Epinephrine 1:100,000 Injection USP
- Starting date:
- August 1, 2013
- Posting date:
- August 22, 2013
- 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-35133
Recalled Products
A. Lidocaine 2% and Epinephrine 1:100,000 Injection USP
Reason
Stability testing at the 15-month time point for the stability lot was out-of-specification for potency of epinephrine (Spec. - lower limit 90%; Actual - 87.2%)
Depth of distribution
Product fabricated for 3 distributors under their private labels with a total of 8 warehousing facilities (British Columbia (2), Alberta (2), Manitoba (1), Ontario (2), Quebec(1)) . Products are destined for dental clinics.
Affected products
A. Lidocaine 2% and Epinephrine 1:100,000 Injection USP
DIN, NPN, DIN-HIM
DIN 00151866
Dosage form
Liquid
Strength
- Epinephrine 0.01 mg/mL
- Lidocaine HCl 20 mg/mL
Lot or serial number
- D00205B
- D00205C
- D00290B
- D00290C
Companies
- Recalling Firm
-
Novocol Pharmaceutical of Canada Inc.
25 Wolseley Court
Cambridge
N1R 6X3
Ontario
CANADA
- Marketing Authorization Holder
-
Novocol Pharmaceutical of Canada Inc.
25 Wolseley Court
Cambridge
N1R 6X3
Ontario
CANADA