PlainRecalls
FDA Drug Moderate Class II Ongoing

Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.

Reported: December 27, 2023 Initiated: December 13, 2023 #D-0152-2024

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.

Details

Units Affected
3,396 bottles
Distribution
NJ
Location
Santa Ana, CA

Frequently Asked Questions

What product was recalled?
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.. Recalled by Private Label Partners, Inc.. Units affected: 3,396 bottles.
Why was this product recalled?
CGMP Deviations: Stability data does not support expiry date.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 27, 2023. Severity: Moderate. Recall number: D-0152-2024.