Recalls / Class II
Class IID-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.
- Affected lot / code info
- SKUs: 903432; 999543; 912968; 999075
Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature 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
- Unknown
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-06-23
- FDA classified
- 2022-08-22
- Posted by FDA
- 2022-08-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1381-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.