Agency classClass IOur severity:Critical FDA (Drugs)·D-0279-2024·Announced 2024-02-07

Phenylephrine IV Bags Recalled for Double-Dose Filling System Malfunction

Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA classified this as a Class I recall, the highest severity classification for drug recalls. The severity rubric identifies FDA Class I recalls as Critical due to the potential for serious adverse health consequences. The filling system malfunction can result in double-dose administration of a potent injectable medication.

Plain-English summary

Denver Solutions, LLC, is recalling 29,016 Phenylephrine HCl IV bags (Item F3360, 20 mg per 250 mL, NDC 71449-148-94). These products were distributed nationwide for intravenous use.

The semi-automated IV bag filling system can malfunction and deliver a double dose to some individual bags. The FDA classified this as a Class I recall, indicating a serious potential for harm from double-dosing with this potent injectable medication.

The affected lot numbers are 2330993, 2331010, 2331055, 2331113, 2331181, 2331187, 2331266, 2331343, 2331349, and 2331433, with expiration dates from January through May 2024.

The recalled product

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.
Manufacturer: Denver Solutions, LLC DBA Leiters Health
Category: Drug — Intravenous
Hazard: dosage-error
overdose-risk
Affected units: 29,016

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Denver Solutions, LLC DBA Leiters Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Denver Solutions, LLC DBA Leiters Health

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