PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: August 31, 2022 Initiated: June 23, 2022 #D-1381-2022

Product Description

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.

Details

Units Affected
Unknown
Distribution
Nationwide within the United States
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Family Dollar Stores, Llc.. Units affected: Unknown.
Why was this product recalled?
CGMP Deviations: product held outside appropriate storage temperature conditions.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 31, 2022. Severity: Moderate. Recall number: D-1381-2022.