D-0152-2024 Class II Ongoing
FDA drug recall D-0152-2024 was initiated by Private Label Partners, Inc. on Dec 13, 2023 and is designated Class II. Reason for recall: CGMP Deviations: Stability data does not support expiry date. The recall status is ongoing. Affected quantity: 3,396 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 27, 2023
- Initiation Date
- Dec 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,396 bottles
Product Description
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.
Distribution Pattern
NJ
Code Information
Lot #220551, Exp: 2/28/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0152-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026