Drug product
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
D-0057-2025
Product summary
- Event
- Event 95659
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3139 boxes
- Official record key
drug-enforcement:D-0057-2025
Official wording
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Code information: Lot# 24A0050, exp. date 04/25/2026; 24A0055, exp. date 05/09/2026; 24A0059, exp. date 05/16/2026; 24A0060, exp. date 05/20/2026; 24A0071, exp. date 06/24/2026; 24A0072, exp. date 06/26/2026
Distribution pattern: USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations