D-1381-2022 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 31, 2022
- Initiation Date
- June 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
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.
Distribution Pattern
Nationwide within the United States
Code Information
SKUs: 903432; 999543; 912968; 999075