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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