Recall archive / FDA drug enforcement
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 0... — FDA record D-0152-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- CGMP Deviations: Stability data does not support expiry date.
- Classification
- Class II
- Recalling firm
- Private Label Partners, Inc.
- Quantity
- 3,396 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0152-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #220551, Exp: 2/28/2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
NJ
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Dec 13, 2023
- Center classification date
- Dec 19, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.