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Oral-B Anti-Bacterial with Fluoride Alcohol Free

Starting date:
July 13, 2011
Posting date:
August 8, 2011
Type of communication:
Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Identification number:
RA-2011A145

Reason

Product produced at P&G's Retycol Contract Manufacturing facility may significantly exceed microbiological specification for total plate count. The microbiological specification has not been confirmed for the Canadian Products at this time. However, it has been confirmed and typed for some product lots, also produced at Retycol CM, which were destined for other countries and has been reported to be a gram negative organism (Burkholderia anthina).

Depth of distribution

The products were distributed nationally in Canada. They were distributed to wholesalers, retailers and distributors. They are available for sale in pharmacies, food and general merchandise retailers. The products are also distributed to dental professionals through distributors.

Affected products

Oral-B Anti-Bacterial with Fluoride Alcohol Free

DIN, NPN, DIN-HIM

DIN 02130823

Dosage form

Mouthwash / Gargle

Strength

0.05%

Lot or serial number

>150 Lot Numbers Contact Manufacturer

Companies

Recalling Firm
Procter & Gamble Inc. 4711 Yonge Street Toronto, Ontario M2N 6K8
Marketing Authorization Holder
Procter & Gamble Inc. 4711 Yonge Street Toronto, Ontario M2N 6K8