FDA Recall D-0279-2024

Denver Solutions, LLC DBA Leiters Health · Englewood, CO

Class I — life-threatening Ongoing 868 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.

Lot / code: Lot #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024.

Quantity: 29,016 IV bags

Reason for recall

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Recall record

Recall number: D-0279-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide within the United States
Recall initiated: 2023-12-28
Classified by FDA Center: 2024-01-29
FDA published: 2024-02-07
Recalling firm: Denver Solutions, LLC DBA Leiters Health
Firm location: Englewood, CO

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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