Drug product
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
D-0250-2025
Product summary
- Event
- Event 96308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3069 Oral Syringes
- Official record key
drug-enforcement:D-0250-2025
Official wording
Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Code information: Lot #: 24300812, Exp 01/31/2025; 24530836, Exp 07/19/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.