FDA Drug Recalls

Recalls / Class II

Class IID-1470-2022

Product

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.

Affected lot / code info
SKUs 999043 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

Why it was recalled

cGMP deviation: Product held outside of appropriate temperature storage conditions.

Recalling firm

Firm
Family Dollar Stores, Llc.
Notification channel
Other
Type
Voluntary: Firm initiated
Address
500 Volvo Pkwy, Chesapeake, Virginia 23320-1604

Distribution

Quantity
840 packages
Distribution pattern
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

Timeline

Recall initiated
2022-08-10
FDA classified
2022-08-29
Posted by FDA
2022-09-07
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1470-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.