FDA Recall D-0152-2024
Private Label Partners, Inc. · Santa Ana, CA
Class II Ongoing 883 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
Reason for recall
CGMP Deviations: Stability data does not support expiry date.
Recall record
- Recall number
D-0152-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- NJ
- Recall initiated
- 2023-12-13
- Classified by FDA Center
- 2023-12-19
- FDA published
- 2023-12-27
- Recalling firm
- Private Label Partners, Inc.
- Firm location
- Santa Ana, 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.