Drug & medication recalls Moderate risk

Selenium Sulfide 2 recalled over manufacturing violations

Recall date
December 13, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 077…
Recall number
D-0152-2024
FDA classification
Class II
Brand / firm
Private Label Partners, Inc.
Sold / distributed
NJ

Why it was recalled

CGMP Deviations: Stability data does not support expiry date.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.

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