FDAClass IIDecember 27, 2023

Selenium Sulfide 2.25% Shampoo recall: CGMP Deviations

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

Why was Selenium Sulfide 2.25% Shampoo recalled?

CGMP Deviations: Stability data does not support expiry date.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #220551, Exp: 2/28/2025

Product
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
Recalling firm
Private Label Partners, Inc.
Quantity
3,396 bottles
Distribution
NJ
Recall date
December 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls