Medications & Supplements/Prescription Drugs

Pharmedium Services, LLC: Ephedrine Sulfate Pre-Filled Syringes Recalled for Subpotency

Agency Publication Date: January 12, 2018

Summary

Pharmedium Services, LLC is recalling 5,002 units of Ephedrine Sulfate (5 mg/mL) in 0.9% Sodium Chloride pre-filled syringes. This medication is being recalled because it was found to be subpotent, meaning the drug is not at its full required strength. This recall affects various 10 mL total volume syringes packaged in both 5-count and 25-count cartons that were distributed nationwide to healthcare facilities. Patients who receive a subpotent dose of this medication may not achieve the intended clinical response during treatment.

Risk

A subpotent drug provides a lower dose than intended, which can lead to ineffective treatment of the patient's condition. In clinical settings where Ephedrine Sulfate is used, such as for treating low blood pressure during anesthesia, an under-dose could fail to stabilize the patient's vital signs.

What You Should Do

Identify if you have the affected Ephedrine Sulfate In 0.9% Sodium Chloride (5 mg per mL, 10 mL total volume) pre-filled syringes by checking for NDC numbers 71030-0003-10, 71030-0003-20, 71030-0003-21, or 71030-0003-12.
Check the syringe packaging for the following lot numbers and expiration dates: 172950036M (Exp. 1/21/2018), 172940003M (Exp. 1/20/2018), 172880044M (Exp. 1/14/2018), 172840176M (Exp. 1/11/2018), 172920115M (Exp. 1/18/2018), 172840015D (Exp. 1/10/2018), or 172930139M (Exp. 1/19/2018).
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received or have possession of this recalled medication.
Return any unused product from the affected lots 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 and replacement process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes

Model:

NDC 71030-0003-10

NDC 71030-0003-20

NDC 71030-0003-21

NDC 71030-0003-12

Code 2R3304

Lot Numbers:

172950036M (Exp. 1/21/2018)

172940003M (Exp. 1/20/2018)

172880044M (Exp. 1/14/2018)

172840176M (Exp. 1/11/2018)

172920115M (Exp. 1/18/2018)

172840015D (Exp. 1/10/2018)

172930139M (Exp. 1/19/2018)

Date Ranges: Expiration dates between January 10, 2018 and January 21, 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78683

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Sold By: Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 5002 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

Identify if you have the affected Ephedrine Sulfate In 0.9% Sodium Chloride (5 mg per mL, 10 mL total volume) pre-filled syringes by checking for NDC numbers 71030-0003-10, 71030-0003-20, 71030-0003-21, or 71030-0003-12.

Check the syringe packaging for the following lot numbers and expiration dates: 172950036M (Exp. 1/21/2018), 172940003M (Exp. 1/20/2018), 172880044M (Exp. 1/14/2018), 172840176M (Exp. 1/11/2018), 172920115M (Exp. 1/18/2018), 172840015D (Exp. 1/10/2018), or 172930139M (Exp. 1/19/2018).

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received or have possession of this recalled medication.

Return any unused product from the affected lots 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 and replacement process.

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

Affected Products

Product: ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes

Model:

NDC 71030-0003-10

NDC 71030-0003-20

NDC 71030-0003-21

NDC 71030-0003-12

Code 2R3304

Lot Numbers:

172950036M (Exp. 1/21/2018)

172940003M (Exp. 1/20/2018)

172880044M (Exp. 1/14/2018)

172840176M (Exp. 1/11/2018)

172920115M (Exp. 1/18/2018)

172840015D (Exp. 1/10/2018)

172930139M (Exp. 1/19/2018)

Date Ranges: Expiration dates between January 10, 2018 and January 21, 2018