← FDA ENFORCEMENT
D-0250-2025Class II

Safecor Health, LLC

Recalling firm
Safecor Health, LLC
Product type
Drug
Status
Ongoing
Report date
2025-03-12
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
3069 Oral Syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

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.

Code / lot info

Lot #: 24300812, Exp 01/31/2025; 24530836, Exp 07/19/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.