December 2023 FDA Recall Drug by Private Label Partners, Inc.
D-0152-2024 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Private Label Partners, Inc. on December 13, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NJ and the recall is currently ongoing.

Recall Number: D-0152-2024

Reason for Recall
CGMP Deviations: Stability data does not support expiry date.
Initiated
12-13-2023
Reported
12-27-2023
Quantity
3,396 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93616
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Private Label Partners, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ
Product Description About Product Description
Full technical description of the product.
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.

Batch or Lot Expiration Information

Lot# 220551, Exp: 2/28/2025