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

  1. Orajel Regular Strength Gel For Teething
  2. 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

  1. 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