FDA Recall D-1470-2022
Family Dollar Stores, Llc. · Chesapeake, VA
Class II Ongoing 1373 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Recall record
- Recall number
D-1470-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Other
- Distribution
- Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
- Recall initiated
- 2022-08-10
- Classified by FDA Center
- 2022-08-29
- FDA published
- 2022-09-07
- Recalling firm
- Family Dollar Stores, Llc.
- Firm location
- Chesapeake, VA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.