Drug product
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
D-0056-2025
Product summary
- Event
- Event 95659
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7488 boxes
- Official record key
drug-enforcement:D-0056-2025
Official wording
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Code information: Lot# 24A0052, exp. date 05/01/2026; 24A0057, exp. date 05/13/2026; 24A0066, exp. date 05/31/2026; 24A0067, exp. date 06/04/2026; 24A0068, exp. date 06/17/2026; 24A0069, exp. date 06/19/2026 24A0075, exp. date 07/08/2026 24A0078, exp. date 07/12/2026
Distribution pattern: USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations