Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
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