FDA recall D-0152-2024

Private Label Partners, Inc. · Class II · drug

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.

Distribution

NJ

Key facts

Status: Ongoing
Initiation date: 2023-12-13
Report date: 2023-12-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0152-2024