The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0443-2023·Announced 2023-03-15

FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations

Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for manufacturing process deviations without reported illnesses or injuries. The hazard is theoretical, and the firm voluntarily corrected the issue, placing this in the Moderate category per the voluntary precautionary recall criterion.

Plain-English summary

Denver Solutions, LLC (doing business as Leiters Health) is recalling approximately 325,300 units of Phenylephrine HCl 1mg per 10mL injectable solution in 10 mL syringes. This is a prescription-only medication. The recall affects 17 lot numbers with expiration dates from March 5, 2023, through July 15, 2023.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The product was distributed nationwide within the United States, including to government facilities and the Department of Veterans Affairs. The firm voluntarily initiated the recall, which was completed as of January 11, 2024.

The FDA classified this as a Class II recall, indicating that while the product may pose a health risk, serious adverse health consequences or death is not likely to result.

The recalled product

Product
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Manufacturer
Denver Solutions, LLC DBA Leiters Health
Category
Drug — Injectable / Prescription
Hazard
Affected units
325,300

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 (20)

  • Lot #: 2230895
  • Exp. Date 3/5/2023
  • 2230911
  • Exp. Date 3/11/2023
  • 2230913
  • Exp. Date 3/18/2023
  • 2230994
  • Exp. Date 3/27/2023
  • 2231006
  • Exp. Date 4/1/2023
  • 2231109
  • Exp. Date 4/19/2023
  • 2231126
  • Exp. Date 5/6/2023
  • 2231134
  • Exp. Date 5/10/2023
  • 2231140
  • Exp. Date 5/14/2023
  • 2231142
  • Exp. Date 5/20/2023

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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