Private Label Partners recalls Selenium Sulfide 2.25% Shampoo due to stability data not supporting the expiry date. This Rx-only product may become ineffective after the stated expiration.
CGMP Deviations: Stability data does not support expiry date.
Private Label Partners is recalling Selenium Sulfide 2.25% Shampoo (180mL, Rx only) because stability testing shows the product may not remain effective past its expiration date. This means the shampoo could become less effective over time, but it does not pose an immediate safety risk.
The product's stability data does not support the expiration date, meaning the shampoo may lose effectiveness over time. This could lead to the treatment not working as intended for scalp conditions like dandruff. However, the product does not pose a risk of injury or harm.
People with a prescription for this shampoo who purchased it from a pharmacy or clinic. Those using it for dandruff or scalp conditions are most at risk of reduced effectiveness.
Check for the 180mL bottle labeled 'Selenium Sulfide 2.25% Shampoo, Rx Only' with NDC 42582-900-06. The product was manufactured for Bi-Coastal Pharma Int. LLC in Shrewsbury, NJ, with lot number 220551 and expiration 2/28/2025.
Verify the expiration date on the bottle (2/28/2025) and compare it to current date.
No, the recall is due to potential reduced effectiveness over time, not a safety hazard.
Look for the 180mL bottle with NDC 42582-900-06, manufactured for Bi-Coastal Pharma Int. LLC in Shrewsbury, NJ, with lot number 220551 and expiration 2/28/2025.
No, but you should check if it has expired and consider using a different product if it's no longer effective.
We’ve drafted a message you can send Private Label Partners to request your refund or repair — edit it as you like.
Subject: Recall D-0152-2024 — Private Label Partners Private Label Partners Hello, I own a Private Label Partners that is covered by recall D-0152-2024 from Private Label Partners. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.