FDA Recall D-0657-2024
PREQUEL SKIN · W Hollywood, CA
Class II Ongoing 624 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
Reason for recall
Microbial contamination of non-sterile Products -
Recall record
- Recall number
D-0657-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Distributed nationwide in USA and on line
- Recall initiated
- 2024-08-28
- Classified by FDA Center
- 2024-09-09
- FDA published
- 2024-09-18
- Recalling firm
- PREQUEL SKIN
- Firm location
- W Hollywood, CA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.