Medications & Supplements/Prescription Drugs

PharMEDium Services, LLC: Various IV Medications Recalled Due to Lack of Sterility Assurance

Agency Publication Date: April 3, 2020

Summary

PharMEDium Services, LLC is recalling 17,045 units of 46 different IV medication lots, including Ephedrine Sulfate, Nicardipine HCl, Rocuronium Bromide, Hydromorphone, Fentanyl Citrate, and Succinylcholine Chloride. These medications are being recalled because they lack sterility assurance, meaning there is a risk the products may be contaminated with microorganisms. If a non-sterile drug is injected into a patient, it can lead to life-threatening infections or other serious health complications. These products were distributed nationwide in the United States and were primarily used in hospital and clinical settings.

Risk

The lack of sterility assurance means the IV medications could contain bacteria or fungi. Injecting a contaminated product directly into the bloodstream can cause serious systemic infections, sepsis, and potentially death, especially in patients with weakened immune systems.

What You Should Do

Identify if you have any of the affected products by checking the NDC and lot numbers on the syringe or bag label. Affected products include: Ephedrine Sulfate (NDC 71030-003-12, 71030-003-09, 71030-003-02, 71030-001-09), Nicardipine HCl (NDC 71019-206-01), Rocuronium Bromide (NDC 71019-321-10, 71019-321-05), Hydromorphone (NDC 61553-166-44), Fentanyl Citrate (NDC 61553-113-50, 61553-672-44, 61553-306-33, 61553-303-28), and Succinylcholine Chloride (NDC 71019-341-04).
Check for specific lot numbers such as 193500004D (Exp 3/16/2020), 193540006D (Exp 3/22/2020), 193510017D (Exp 3/17/2020), 193510022D (Exp 3/17/2020), 193610002D (Exp 3/29/2020), and other codes listed in the product details.
Immediately stop using any affected medication and quarantine the product to prevent further use.
Contact your healthcare provider or pharmacist for guidance regarding any concerns about potential exposure to these non-sterile products.
Return any unused or remaining product to the pharmacy or place of purchase for a refund and contact PharMEDium Services, LLC for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe

Model:

NDC 71030-003-12

Lot Numbers:

193500004D (Exp 3/16/2020)

193510006D (Exp 3/17/2020)

193530011D (Exp 3/19/2020)

193570003D (Exp 3/23/2020)

Date Ranges: 3/16/2020, 3/17/2020, 3/19/2020, 3/23/2020

Product: nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe

Model:

NDC 71019-206-01

Lot Numbers:

193540006D (Exp 3/22/2020)

Date Ranges: 3/22/2020

Product: rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe

Model:

NDC 71019-321-10

Lot Numbers:

193510017D (Exp 3/17/2020)

193530001D (Exp 3/19/2020)

193540002D (Exp 3/22/2020)

Date Ranges: 3/17/2020, 3/19/2020, 3/22/2020

Product: HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe

Model:

NDC 61553-166-44

Lot Numbers:

193510022D (Exp 3/17/2020)

193510023D (Exp 3/17/2020)

193580012D (Exp 3/25/2020)

193600013D (Exp 3/26/2020)

193640016D (Exp 3/30/2020)

193530020D (Exp 3/19/2020)

193540023D (Exp 3/22/2020)

193540026D (Exp 3/22/2020)

Date Ranges: 3/17/2020 - 3/30/2020

Product: fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag

Model:

NDC 61553-113-50

Lot Numbers:

193610002D (Exp 3/29/2020)

Date Ranges: 3/29/2020

Product: succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe

Model:

NDC 71019-341-04

Lot Numbers:

193500014D (Exp 3/16/2020)

193510018D (Exp 3/17/2020)

Date Ranges: 3/16/2020, 3/17/2020

Product: rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe

Model:

NDC 71019-321-05

Lot Numbers:

193500019D (Exp 3/16/2020)

193510014D (Exp 3/17/2020)

193520009D (Exp 3/18/2020)

Date Ranges: 3/16/2020, 3/17/2020, 3/18/2020

Product: ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe

Model:

NDC 71030-003-09

Lot Numbers:

193500012D (Exp 3/16/2020)

Date Ranges: 3/16/2020

Product: fentaNYL Citrate 50 mcg per mL Injection, 1,500 mcg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe

Model:

NDC 61553-672-44

Lot Numbers:

193510008D (Exp 3/17/2020)

193580004D (Exp 3/25/2020)

Date Ranges: 3/17/2020, 3/25/2020

Product: ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe

Model:

NDC 71030-003-02

Lot Numbers:

193510031D (Exp 3/17/2020)

Date Ranges: 3/17/2020

Product: ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% Sodium Chloride 5 mL syringe

Model:

NDC 71030-001-09

Lot Numbers:

193520006D (Exp 3/18/2020)

193530009D (Exp 3/19/2020)

Date Ranges: 3/18/2020, 3/19/2020

Product: fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe

Model:

NDC 61553-306-33

Lot Numbers:

193530007D (Exp 3/19/2020)

Date Ranges: 3/19/2020

Product: fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL syringe

Model:

NDC 61553-303-28

Lot Numbers:

193520008D (Exp 3/18/2020)

193540005D (Exp 3/22/2020)

Date Ranges: 3/18/2020, 3/22/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85212

Status: Resolved

Manufacturer: PharMEDium Services, LLC

Sold By: Hospitals; Medical Clinics; Healthcare Facilities

Manufactured In: United States

Units Affected: 13 products (1075 units; 80 units; 4625 units; 1840 units; 210 units; 2475 units; 2250 units; 375 units; 290 units; 1500 units; 900 units; 75 units; 1350 units)

Distributed To: Nationwide

Agency Last Updated: April 6, 2020

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 any of the affected products by checking the NDC and lot numbers on the syringe or bag label. Affected products include: Ephedrine Sulfate (NDC 71030-003-12, 71030-003-09, 71030-003-02, 71030-001-09), Nicardipine HCl (NDC 71019-206-01), Rocuronium Bromide (NDC 71019-321-10, 71019-321-05), Hydromorphone (NDC 61553-166-44), Fentanyl Citrate (NDC 61553-113-50, 61553-672-44, 61553-306-33, 61553-303-28), and Succinylcholine Chloride (NDC 71019-341-04).

Check for specific lot numbers such as 193500004D (Exp 3/16/2020), 193540006D (Exp 3/22/2020), 193510017D (Exp 3/17/2020), 193510022D (Exp 3/17/2020), 193610002D (Exp 3/29/2020), and other codes listed in the product details.

Immediately stop using any affected medication and quarantine the product to prevent further use.

Contact your healthcare provider or pharmacist for guidance regarding any concerns about potential exposure to these non-sterile products.

Return any unused or remaining product to the pharmacy or place of purchase for a refund and contact PharMEDium Services, LLC for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe

Model:

NDC 71030-003-12

Lot Numbers:

193500004D (Exp 3/16/2020)

193510006D (Exp 3/17/2020)

193530011D (Exp 3/19/2020)

193570003D (Exp 3/23/2020)

Date Ranges: 3/16/2020, 3/17/2020, 3/19/2020, 3/23/2020

Product: nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe

Model:

NDC 71019-206-01

Lot Numbers:

193540006D (Exp 3/22/2020)

Date Ranges: 3/22/2020

Product: rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe

Model:

NDC 71019-321-10

Lot Numbers:

193510017D (Exp 3/17/2020)

193530001D (Exp 3/19/2020)

193540002D (Exp 3/22/2020)

Date Ranges: 3/17/2020, 3/19/2020, 3/22/2020

Product: HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe

Model:

NDC 61553-166-44

Lot Numbers:

193510022D (Exp 3/17/2020)

193510023D (Exp 3/17/2020)

193580012D (Exp 3/25/2020)

193600013D (Exp 3/26/2020)

193640016D (Exp 3/30/2020)

193530020D (Exp 3/19/2020)

193540023D (Exp 3/22/2020)

193540026D (Exp 3/22/2020)

Date Ranges: 3/17/2020 - 3/30/2020

Product: fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag

Model:

NDC 61553-113-50

Lot Numbers:

193610002D (Exp 3/29/2020)

Date Ranges: 3/29/2020

Product: succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe

Model:

NDC 71019-341-04

Lot Numbers:

193500014D (Exp 3/16/2020)

193510018D (Exp 3/17/2020)

Date Ranges: 3/16/2020, 3/17/2020

Product: rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe

Model:

NDC 71019-321-05

Lot Numbers:

193500019D (Exp 3/16/2020)

193510014D (Exp 3/17/2020)

193520009D (Exp 3/18/2020)

Date Ranges: 3/16/2020, 3/17/2020, 3/18/2020

Product: ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe

Model:

NDC 71030-003-09

Lot Numbers:

193500012D (Exp 3/16/2020)

Date Ranges: 3/16/2020

Product: fentaNYL Citrate 50 mcg per mL Injection, 1,500 mcg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe

Model:

NDC 61553-672-44

Lot Numbers:

193510008D (Exp 3/17/2020)

193580004D (Exp 3/25/2020)

Date Ranges: 3/17/2020, 3/25/2020

Product: ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe

Model:

NDC 71030-003-02

Lot Numbers:

193510031D (Exp 3/17/2020)

Date Ranges: 3/17/2020

Product: ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% Sodium Chloride 5 mL syringe

Model:

NDC 71030-001-09

Lot Numbers:

193520006D (Exp 3/18/2020)

193530009D (Exp 3/19/2020)

Date Ranges: 3/18/2020, 3/19/2020

Product: fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe

Model:

NDC 61553-306-33

Lot Numbers:

193530007D (Exp 3/19/2020)

Date Ranges: 3/19/2020

Product: fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL syringe

Model:

NDC 61553-303-28

Lot Numbers:

193520008D (Exp 3/18/2020)

193540005D (Exp 3/22/2020)

Date Ranges: 3/18/2020, 3/22/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85212

Status: Resolved

Manufacturer: PharMEDium Services, LLC

Sold By: Hospitals; Medical Clinics; Healthcare Facilities

Manufactured In: United States

Units Affected: 13 products (1075 units; 80 units; 4625 units; 1840 units; 210 units; 2475 units; 2250 units; 375 units; 290 units; 1500 units; 900 units; 75 units; 1350 units)

Distributed To: Nationwide

Agency Last Updated: April 6, 2020