Oragel Recall (2018-05-29)
- Starting date:
- May 29, 2018
- Type of communication:
- Drug Recall
- Subcategory:
- Natural health products
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67490
Recalled Products
- Orajel Regular Strength Gel For Teething
- Orajel Extra Strength Gel For Nighttime
Reason
Precautionary recall based on US FDA’s position regarding oral benzocaine products for infants and children under 2.
Depth of distribution
Wholesalers, Retailers
Affected products
-
Orajel Regular Strength Gel For Teething
DIN, NPN, DIN-HIM
NPN 00075876
Dosage form
Gel
Strength
Benzocaine 7.5% w/w
Lot or serial number
KK616101, KK625701, KK630801, KK705901, KK715801, KK728301, KK808501
Companies
- Recalling Firm
-
Church and Dwight Canada Corp.
5485 Ferrier Street
Montreal
H4P 1M6
Quebec
CANADA
- Marketing Authorization Holder
-
Church and Dwight Canada Corp.
5485 Ferrier Street
Montreal
H4P 1M6
Quebec
CANADA
B. Orajel Extra Strength Gel For Nighttime
DIN, NPN, DIN-HIM
NPN 02256401
Dosage form
Gel
Strength
Benzocaine 10% w/w
Lot or serial number
KK634001, KK708601, KK722701, KK736101
Companies
- Recalling Firm
-
Church and Dwight Canada Corp.
5485 Ferrier Street
Montreal
H4P 1M6
Quebec
CANADA
- Marketing Authorization Holder
-
Church and Dwight Canada Corp.
5485 Ferrier Street
Montreal
H4P 1M6
Quebec
CANADA