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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
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.
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