The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0444-2023·Announced 2023-03-15

FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

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 3/5 (High).

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 drug recall for manufacturing practice deviations in an intravenous medication meets the rubric criterion of a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Phenylephrine HCl 40 mg (160 mcg/mL) compounded in 0.9% Sodium Chloride 250 mL IV bags manufactured by Denver Solutions, LLC (Leiters Health) are being recalled. The affected product has NDC 71449-150-82 with Lot #2231017, expiring March 12, 2023. A total of 1,212 units were distributed.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Denver Solutions voluntarily initiated the recall on February 21, 2023, and the FDA classified it as a Class II recall.

The affected product was distributed nationwide throughout the United States, including to Department of Veterans Affairs facilities and other government healthcare facilities. Healthcare providers that received this product should immediately quarantine and return any remaining units.

Any facility or provider with this product should not use it and should contact the manufacturer or their pharmaceutical supplier for return or destruction procedures. This recall was officially terminated on January 11, 2024.

The recalled product

Product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Manufacturer
Denver Solutions, LLC DBA Leiters Health
Category
Drug — Compounded Intravenous Injection
Hazard
Affected units
1,212

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 #: 2231017
  • Exp. Date 3/12/2023

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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