D-1381-2022 Class II Ongoing
FDA drug recall D-1381-2022 was initiated by Family Dollar Stores, Llc. on Jun 23, 2022 and is designated Class II. Reason for recall: CGMP Deviations: product held outside appropriate storage temperature conditions. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 31, 2022
- Initiation Date
- Jun 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1381-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026