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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Although this is an FDA Class I recall, no illnesses or injuries have been reported and the hazard is potential rather than confirmed. Per the rubric, this qualifies as a high-severity risk-of-harm product where injury has not yet been reported.
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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