FDA-Drug2022-08-31Class II

ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.
Hazard

CGMP Deviations: product held outside appropriate storage temperature conditions.

Sold states
Nationwide within the United States
Affected count
Unknown
Manufactured in
500 Volvo Pkwy, Chesapeake, VA, United States
Products
ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2022

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