PHENYLephrine HCl Injection Syringes Recalled for Lack of Sterility
Denver Solutions, LLC DBA Leiters Health is recalling PHENYLephrine HCl 0.5 mg per 5mL single-dose syringes because some syringes may be leaking or damaged, which could compromise sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: This is an FDA Class II recall involving a pharmaceutical injection product. Lack of sterility assurance in injectable products poses a risk of serious infection, which meets the Severe criteria for Class II recalls with risk of harm.
Plain-English summary
Denver Solutions, LLC DBA Leiters Health is recalling PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL single-dose syringes, Rx only. The product is manufactured by Denver Solutions, LLC DBA Leiters Health, located at 13796 Compark Blvd, Englewood, CO 80112. The National Drug Code (NDC) is 71449-001-11. The recalled lot is 2431349A with an expiration date of 6/16/2025.
The recall has been issued because some syringes may be leaking or damaged, which could compromise the assurance of sterility.
The affected product was distributed nationwide in the U.S.A. Approximately 7,290 syringes are subject to this recall. Patients and healthcare providers who have received or administered this product should contact their healthcare provider or pharmacy with questions or concerns.
The recalled product
- Product
- PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Affected units
- 7,290
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 (2)
- Lot #: 2431349A
- Exp.: 6/16/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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