Why it was recalled
CGMP Deviations: Stability data does not support expiry date.
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.
Lot numbers, UPCs & expiration codes
Lot #220551, Exp: 2/28/2025
Where it was sold
NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0152-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 13, 2023
- FDA report date
- Dec 27, 2023
- Quantity
- 3,396 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Private Label Partners, Inc.
Original FDA data
Every field from FDA enforcement report D-0152-2024, exactly as published.
Show all FDA fields
- City
- Santa Ana
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 93616
- Address
- 551 N Fairview St
- Code information
- Lot #220551, Exp: 2/28/2025
- Postal code
- 92703-1806
- Report date
- Dec 27, 2023
- Product type
- Drugs
- Recall number
- D-0152-2024
- Classification
- Class II
- Recalling firm
- Private Label Partners, Inc.
- Product quantity
- 3,396 bottles
- Reason for recall
- CGMP Deviations: Stability data does not support expiry date.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- NJ
- Recall initiation date
- Dec 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 19, 2023