Medications & Supplements/Prescription Drugs

PharMEDium Services, LLC: Fentanyl, Ephedrine, and Rocuronium Recalled for Manufacturing Deviations

Agency Publication Date: August 3, 2018

Summary

PharMEDium Services, LLC has recalled 1,255 units of various injectable medications, including Fentanyl Citrate, Ephedrine Sulfate, and Rocuronium Bromide. These products were distributed to healthcare facilities while a cleanroom hood certification discrepancy was being investigated. Because the sterility of the environment cannot be guaranteed, these products could potentially be contaminated, posing a risk to patients.

Risk

The medications were prepared in a cleanroom hood that may not have met safety certifications at the time of production, which could result in a lack of sterility. If a non-sterile drug is injected into a patient, it can cause life-threatening infections or serious systemic illness.

What You Should Do

Check your medical supplies for 10 mcg/mL Fentanyl Citrate in 0.9% Sodium Chloride (250 mL or 100 mL Intravia Bags) with lot numbers 181760013D or 181730007D and expiration dates of 08/09/2018 or 09/02/2018.
Check for 5 mg/mL Ephedrine Sulfate in 0.9% Sodium Chloride (5 mL syringe) with lot number 181730039D and expiration date 09/20/2018.
Check for 10 mg/mL Rocuronium Bromide (5 mL syringe) with lot number 181780003D.
If you are a patient who has received any of these medications and are experiencing unusual symptoms, contact your healthcare provider or pharmacist immediately for guidance.
Healthcare facilities and pharmacists should immediately stop using these specific lots and return any unused product to the place of purchase for a refund.
Contact PharMEDium Services, LLC at their Dayton, New Jersey facility or via their corporate website for specific return instructions and to report any adverse events.
For further information or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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: 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride (250 mL in 250 mL Intravia Bag)

Model:

Recall #: D-1043-2018

Lot Numbers:

181760013D (Exp 08/09/2018)

181730007D (Exp 09/02/2018)

Date Ranges: 08/09/2018, 09/02/2018

Product: 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride (100 mL in 150 mL Intravia Bag)

Model:

Recall #: D-1043-2018

Lot Numbers:

181760013D (Exp 08/09/2018)

181730007D (Exp 09/02/2018)

Date Ranges: 08/09/2018, 09/02/2018

Product: 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride (5 mL in 5 mL BD Syringe)

Model:

Recall #: D-1044-2018

Lot Numbers:

181730039D (Exp 09/20/2018)

Date Ranges: 09/20/2018

Product: 10 mg/mL Rocuronium Bromide (Preservative Free) (5 mL BD Syringe)

Model:

Recall #: D-1045-2018

Lot Numbers:

181780003D

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80638

Status: Resolved

Manufacturer: PharMEDium Services, LLC

Sold By: Hospitals; Healthcare Facilities

Manufactured In: United States

Units Affected: 3 products (230 Intravia Bags; 450 Syringes; 575 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 10 mcg/mL Fentanyl Citrate in 0.9% Sodium Chloride (250 mL or 100 mL Intravia Bags) with lot numbers 181760013D or 181730007D and expiration dates of 08/09/2018 or 09/02/2018.

Check for 5 mg/mL Ephedrine Sulfate in 0.9% Sodium Chloride (5 mL syringe) with lot number 181730039D and expiration date 09/20/2018.

Check for 10 mg/mL Rocuronium Bromide (5 mL syringe) with lot number 181780003D.

If you are a patient who has received any of these medications and are experiencing unusual symptoms, contact your healthcare provider or pharmacist immediately for guidance.

Healthcare facilities and pharmacists should immediately stop using these specific lots and return any unused product to the place of purchase for a refund.

Contact PharMEDium Services, LLC at their Dayton, New Jersey facility or via their corporate website for specific return instructions and to report any adverse events.

For further information or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride (250 mL in 250 mL Intravia Bag)

Model:

Recall #: D-1043-2018

Lot Numbers:

181760013D (Exp 08/09/2018)

181730007D (Exp 09/02/2018)

Date Ranges: 08/09/2018, 09/02/2018

Product: 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride (100 mL in 150 mL Intravia Bag)

Model:

Recall #: D-1043-2018

Lot Numbers:

181760013D (Exp 08/09/2018)

181730007D (Exp 09/02/2018)

Date Ranges: 08/09/2018, 09/02/2018

Product: 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride (5 mL in 5 mL BD Syringe)

Model:

Recall #: D-1044-2018

Lot Numbers:

181730039D (Exp 09/20/2018)

Date Ranges: 09/20/2018

Product: 10 mg/mL Rocuronium Bromide (Preservative Free) (5 mL BD Syringe)

Model:

Recall #: D-1045-2018

Lot Numbers:

181780003D