Recalls / Class II
Class IID-0250-2025
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.
- Affected lot / code info
- Lot #: 24300812, Exp 01/31/2025; 24530836, Exp 07/19/2025
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4060 Business Park Dr Ste B, Columbus, Ohio 43204-5047
Distribution
- Quantity
- 3069 Oral Syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-02-17
- FDA classified
- 2025-03-05
- Posted by FDA
- 2025-03-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0250-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.