The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0442-2023·Announced 2023-03-15

Phenylephrine HCl syringe recalled for manufacturing practice deviations

Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.

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: FDA Class II recall for manufacturing practice deviations with no reported illnesses or injuries. The firm initiated the recall voluntarily as a precautionary measure and the recall was later terminated.

Plain-English summary

Denver Solutions, LLC, operating as Leiters Health, is recalling 13,445 units of Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL) in 5 mL syringes, NDC 71449-001-11. This prescription medication was distributed nationwide, including to government facilities.

The firm initiated this voluntary recall on February 21, 2023, due to Current Good Manufacturing Practice (CGMP) deviations discovered at the manufacturing facility. The affected product lots are numbered 2230960 (expiration March 12, 2023) and 2231080 (expiration April 9, 2023).

If you have received product from these lots, contact the firm or the FDA for return guidance. The recall was terminated on January 11, 2024, after the manufacturing issue was resolved.

The recalled product

Product
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Manufacturer
Denver Solutions, LLC DBA Leiters Health
Category
Drug — Prescription Injectable
Hazard
Affected units
13,445

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 (4)

  • Lot #: 2230960
  • Exp date 3/12/2023
  • 2231080
  • Exp date 4/9/2023.

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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