Medications & Supplements/Prescription Drugs

Pharmedium Services, LLC: Phenylephrine HCL Syringes Recalled for Superpotency

Agency Publication Date: January 12, 2018

Summary

Pharmedium Services, LLC has recalled 2,390 syringes of Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride. This medication was distributed in 10 mL syringes across the United States. The recall was initiated because the drug was found to be superpotent, meaning it contains a higher concentration of the active ingredient than specified, which could lead to serious medical complications. Consumers who have these syringes should not use them and should consult their healthcare provider or pharmacist immediately.

Risk

Superpotent phenylephrine can cause dangerously high blood pressure (hypertension) and a severe decrease in heart rate, which may lead to cardiovascular stress or other life-threatening events.

What You Should Do

Check your medical supplies for Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes with NDC 71019-263-20.
Verify the lot information on the syringe label to see if it matches Lot #: 172560019M with an expiration date of 12/13/2017.
Immediately stop using any syringes from the affected lot and set them aside to ensure they are not administered.
Contact your healthcare provider or pharmacist for guidance regarding this recall and to arrange for an alternative supply.
Return any unused product from this lot to the pharmacy or place of purchase for a refund.
Contact Pharmedium Services, LLC at their Lake Forest, Illinois headquarters for further instructions regarding the return process.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride (10 mL syringe)

Model:

NDC 71019-263-20

Recall #: D-0221-2018

Lot Numbers:

172560019M (Exp. 12/13/2017)

Date Ranges: 12/13/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78695

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Sold By: Hospitals; Healthcare Facilities

Manufactured In: United States

Units Affected: 2390 syringes

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

Check your medical supplies for Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes with NDC 71019-263-20.

Verify the lot information on the syringe label to see if it matches Lot #: 172560019M with an expiration date of 12/13/2017.

Immediately stop using any syringes from the affected lot and set them aside to ensure they are not administered.

Contact your healthcare provider or pharmacist for guidance regarding this recall and to arrange for an alternative supply.

Return any unused product from this lot to the pharmacy or place of purchase for a refund.

Contact Pharmedium Services, LLC at their Lake Forest, Illinois headquarters for further instructions regarding the return process.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.