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Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. L...

FDA Recall #D-0152-2024 — Class II — December 13, 2023

Recall #D-0152-2024 Date: December 13, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

Private Label Partners, Inc. — Santa Ana, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,396 bottles

Distribution

NJ

Code Information

Lot #220551, Exp: 2/28/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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