FDA-Drug2025-03-12Class II

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.

Safecor Health, LLC
Hazard

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Sold states
Nationwide in the USA
Affected count
3069 Oral Syringes
Manufactured in
4060 Business Park Dr Ste B, Columbus, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0250-2025

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