Drug Enforcement D-0250-2025

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

Status

Ongoing

Classification

Class II

Report Date

March 12, 2025

Termination Date

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Product Information

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.
Product quantity
3069 Oral Syringes
Reason for recall
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Safecor Health, LLC
Address
4060 Business Park Dr Ste B

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0250-2025
Event ID
96308
Recall initiation date
February 17, 2025
Center classification date
March 5, 2025
Code info
Lot #: 24300812, Exp 01/31/2025; 24530836, Exp 07/19/2025
More code info
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