The Recall Desk
HighFDA (Drugs)·D-0445-2023·Announced 2023-03-15

FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations

Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.

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: FDA Class II recall of an IV pharmaceutical due to manufacturing practice deviations. Manufacturing quality issues in an injectable product present inherent risk via direct intravenous route. No reported illnesses or injuries; score limited to maximum of 3 per rubric.

Plain-English summary

Denver Solutions, LLC, doing business as Leiters Health, is recalling Phenylephrine HCl 20 mg (80 mcg/mL) in 0.9% Sodium Chloride 250 mL IV bags nationwide. The FDA classified this as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations during the manufacturing process.

The affected product includes 8,136 units distributed nationwide within the United States, including to Veterans Affairs facilities and other government healthcare providers. Affected lots include: Lot 2231026 (Exp. Date 2/23/2023), Lot 2231051 (Exp. Date 3/11/2023), Lot 2231156 (Exp. Date 5/29/2023), Lot 2231163 (Exp. Date 3/26/2023), Lot 223130 (Exp. Date 5/7/2023), and Lot 2231308 (Exp. Date 5/11/2023).

This is a prescription injectable solution delivered to healthcare facilities nationwide. Institutions that have received this product should immediately check their inventory against the affected lot numbers and contact Denver Solutions for instructions on proper handling and disposition of the affected units.

This voluntary recall was initiated by the manufacturer on February 21, 2023, and terminated on January 11, 2024.

The recalled product

Product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Manufacturer
Denver Solutions, LLC DBA Leiters Health
Category
Drug — Injectable
Hazard
Affected units
8,136

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 (12)

  • Lot #: 2231026
  • Exp. Date 2/23/2023
  • 2231051
  • Exp. Date 3/11/2023
  • 2231156
  • Exp. Date 5/29/2023
  • 2231163
  • Exp. Date 3/26/2023
  • 223130
  • Exp. Date 4 5/7/2023
  • 2231308
  • Exp. Date 5/11/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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Same manufacturer · Denver Solutions, LLC DBA Leiters Health

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