IV Phenylephrine Bags Recalled Due to Potential Double-Dose Delivery System Malfunction
Denver Solutions is recalling 12,564 bags of PHENYLephrine HCl IV solution nationwide due to a semi-automated filling system malfunction that could dispense double doses to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags."
Plain-English summary
Denver Solutions, LLC (operating as Leiters Health) is recalling PHENYLephrine HCl 40 mg per 250 mL IV bags nationwide. The product, identified by item number F3352 and NDC 71449-150-82, comprises 12,564 affected bags.
A malfunction in the company's semi-automated IV bag filling system can cause it to dispense a double dose of the medication into individual bags. Double-dosing poses a risk of serious patient harm.
The affected lots are: 2330939 (expires 01/30/2024), 2331032 (expires 02/03/2024), 2331112 (expires 03/19/2024), 2331190 (expires 03/26/2024), and 2331429 (expires 04/28/2024). Healthcare providers should quarantine affected bags and discontinue their use. Anyone with questions should contact Denver Solutions or the FDA.
The recalled product
- Product
- PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — IV Medication
- Affected units
- 12,564
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 (10)
- Lot #: 2330939
- Exp. Date 01/30/2024
- 2331032
- Exp. Date 02/03/2024
- 2331112
- Exp. Date 03/19/2024
- 2331190
- Exp. Date 03/26/2024
- 2331429
- Exp. Date 04/28/2024.
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.
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