Drug product
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
D-0152-2024
Product summary
- Event
- Event 93616
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,396 bottles
- Official record key
drug-enforcement:D-0152-2024
Official wording
Reason: CGMP Deviations: Stability data does not support expiry date.
Code information: Lot #220551, Exp: 2/28/2025
Distribution pattern: NJ
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Stability data does not support expiry