Selenium Sulfide 2.25% Shampoo Recalled Due to Unsupported Expiry Date
Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo (3,396 bottles, Lot #220551) due to stability data insufficient to support the labeled expiration date. Affected product distributed in New Jersey.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with stability data insufficient to support the labeled expiration date. While no illnesses or injuries have been reported, improper expiry dating presents a risk of harm through potential product degradation and loss of efficacy. Per the rubric, recalls with theoretical hazards and no reported harm are capped at Score 3.
Plain-English summary
Private Label Partners, Inc. is recalling Selenium Sulfide 2.25% Shampoo, 180mL bottles (Rx Only) due to a U.S. Food and Drug Administration (FDA) Class II quality defect.
The manufacturer found that stability data does not adequately support the labeled expiration date of February 28, 2025. This means the product may not remain stable or effective through the stated expiration date, potentially compromising product quality and patient safety.
The recall affects 3,396 bottles with Lot #220551 that were distributed in New Jersey. The product is a prescription-only topical shampoo manufactured for Bi-Coastal Pharma Int. LLC.
Consumers who have this product should not use it beyond what the stability data supports and should consult their healthcare provider or pharmacist for guidance on disposal or replacement of their medication.
The recalled product
- Product
- Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
- Manufacturer
- Private Label Partners, Inc.
- Category
- Drug — Antifungal Shampoo
- Affected units
- 3,396
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #220551
- Exp: 2/28/2025
Distribution
Distributed in 1 state:
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