Medications & Supplements/Prescription Drugs

Leiters Health Phenylephrine HCl Recalled for Manufacturing Deviations

Agency Publication Date: March 7, 2023

Summary

Leiters Health (Denver Solutions, LLC) is recalling approximately 348,093 units of various Phenylephrine HCl medications, including pre-filled syringes and IV bags. The recall is being issued due to manufacturing deviations (Current Good Manufacturing Practice deviations), which could compromise the quality and safety of the drugs. These medications were distributed nationwide to hospitals, clinics, and government facilities, including the VA. No injuries or incidents have been reported in connection with these products.

Risk

Manufacturing deviations can result in medications that do not meet established safety or potency standards, potentially leading to ineffective treatment. While no injuries have been reported, the use of compromised medications poses a risk to patient health.

What You Should Do

This recall affects Phenylephrine HCl syringes and IV bags in various strengths (0.5mg, 1mg, 20mg, and 40mg) sold under the Leiters Health brand.
Hospital and clinic staff should immediately stop using the recalled products and quarantine any remaining stock.
Check the NDC codes 71449-001-11, 71449-001-15, 71449-150-82, and 71449-148-94 and the lot numbers printed on the syringe or IV bag labels. See the Affected Products section below for the full list of affected codes.
Contact Denver Solutions, LLC (DBA Leiters Health) or your distributor directly to arrange for the return of any affected products.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringeby Leiters Health

Variants: 5 mL Syringe, 100 mcg/mL

Lot Numbers:

2230960 (Exp date 3/12/2023)

2231080 (Exp date 4/9/2023)

NDC:

71449-001-11

Product: Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringesby Leiters Health

Variants: 10 mL syringe, 100 mcg/mL

Lot Numbers:

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)

2231156 (Exp. Date 5/29/2023)

2231273 (Exp. Date 6/3/2023)

2231285 (Exp. Date 6/10/2023)

2231299 (Exp. Date 6/17/2023)

2231331 (Exp. Date 6/26/2023)

2330014 (Exp. Date 7/9/2023)

2330025 (Exp. Date 7/15/2023)

NDC:

71449-001-15

Product: Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bagby Leiters Health

Variants: 250 mL IV Bag, 160 mcg/mL

Lot Numbers:

2231017 (Exp. Date 3/12/2023)

NDC:

71449-150-82

Product: Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bagby Leiters Health

Variants: 250 mL IV Bag, 80 mcg/mL

Lot Numbers:

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)

NDC:

71449-148-94

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91762

Status: Resolved

Manufacturer: Denver Solutions, LLC DBA Leiters Health

Sold By: VA facilities; Government facilities; Hospitals; Clinics

Manufactured In: United States

Units Affected: 4 products (13,445 units; 325,300 units; 1212 units; 8,136 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Phenylephrine HCl syringes and IV bags in various strengths (0.5mg, 1mg, 20mg, and 40mg) sold under the Leiters Health brand.

Hospital and clinic staff should immediately stop using the recalled products and quarantine any remaining stock.

Check the NDC codes 71449-001-11, 71449-001-15, 71449-150-82, and 71449-148-94 and the lot numbers printed on the syringe or IV bag labels. See the Affected Products section below for the full list of affected codes.

Contact Denver Solutions, LLC (DBA Leiters Health) or your distributor directly to arrange for the return of any affected products.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Affected Products

Product: Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringeby Leiters Health

Variants: 5 mL Syringe, 100 mcg/mL

Lot Numbers:

2230960 (Exp date 3/12/2023)

2231080 (Exp date 4/9/2023)

NDC:

71449-001-11

Product: Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringesby Leiters Health

Variants: 10 mL syringe, 100 mcg/mL

Lot Numbers:

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)

2231156 (Exp. Date 5/29/2023)

2231273 (Exp. Date 6/3/2023)

2231285 (Exp. Date 6/10/2023)

2231299 (Exp. Date 6/17/2023)

2231331 (Exp. Date 6/26/2023)

2330014 (Exp. Date 7/9/2023)

2330025 (Exp. Date 7/15/2023)

NDC:

71449-001-15

Product: Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bagby Leiters Health

Variants: 250 mL IV Bag, 160 mcg/mL

Lot Numbers:

2231017 (Exp. Date 3/12/2023)

NDC:

71449-150-82

Product: Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bagby Leiters Health

Variants: 250 mL IV Bag, 80 mcg/mL

Lot Numbers:

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)

NDC:

71449-148-94

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91762

Status: Resolved

Manufacturer: Denver Solutions, LLC DBA Leiters Health

Sold By: VA facilities; Government facilities; Hospitals; Clinics

Manufactured In: United States

Units Affected: 4 products (13,445 units; 325,300 units; 1212 units; 8,136 units)

Distributed To: Nationwide