D-0152-2024 Class II Ongoing

Recalled by Private Label Partners, Inc. — Santa Ana, CA

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

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0152-2024. Report a data issue: hello@regdatalab.com.