Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0....

FDA Recall #D-0250-2025 — Class II — February 17, 2025

Recall #D-0250-2025 Date: February 17, 2025 Classification: Class II Status: Ongoing

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.

Reason for Recall

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

Recalling Firm

Safecor Health, LLC — Columbus, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3069 Oral Syringes

Distribution

Nationwide in the USA

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated