FDA recall D-1381-2022

Product

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.

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2022-06-23

Report date

2022-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesapeake, VA, United States

Primary source

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