Medications & Supplements/Prescription Drugs

Pharmedium Services, LLC: Various Injectable Medications Recalled Due to Lack of Sterility Assurance

Agency Publication Date: February 20, 2018

Summary

Pharmedium Services, LLC is recalling 42 different types of injectable medications, including common drugs like HYDROmorphone HCl, Fentanyl, and Midazolam, because they may not be sterile. The recall affects at least 297 bags of Bupivacaine HCl and unknown quantities of other medications, covering all lots currently within their expiration dates. These products were distributed nationwide in the United States to healthcare facilities for patient use. Patients who received these medications should be aware that the lack of sterility could lead to serious infections.

Risk

A lack of sterility assurance in injectable drugs means the medication may be contaminated with microorganisms. If an unsterile product is injected directly into a patient's bloodstream or tissue, it can cause severe, life-threatening infections or sepsis.

What You Should Do

Identify if you have any of the 42 recalled medications from Pharmedium Services, LLC, which include various doses and strengths of drugs such as HYDROmorphone, Fentanyl, Morphine, Midazolam, Ketamine, and Lidocaine.
Check the medication packaging for the manufacturer name 'Pharmedium Services, LLC' and verify the recall number against the list of 42 affected products (ranging from D-0428-2018 to D-0469-2018).
Confirm if the product is 'within expiry,' as the recall includes all lots that have not yet reached their expiration date.
Immediately stop using the affected products and secure them to prevent further use in clinical settings.
Contact your healthcare provider or pharmacist immediately for guidance if you have been administered any of these medications and are experiencing unusual symptoms.
Return any unused recalled product to the pharmacy or place of purchase for a refund and contact Pharmedium Services, LLC for further instructions regarding the return process.
For additional questions or to report a complaint, 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: HYDROmorphone HCl in Sodium Chloride 0.9%

Model:

Recall #: D-0428-2018

Lot Numbers:

All lots remaining within expiry

Product: Bupivacaine HCl in 0.9% Sodium Chloride (297 bags)

Model:

Recall #: D-0429-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0430-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0431-2018

Lot Numbers:

All lots remaining within expiry

Product: Ephedrine Sulfate in 0.9% Sodium Chloride

Model:

Recall #: D-0432-2018

Lot Numbers:

All lots remaining within expiry

Product: HYDROmorphone HCl Injection

Model:

Recall #: D-0433-2018

Lot Numbers:

All lots remaining within expiry

Product: Midazolam HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0434-2018

Lot Numbers:

All lots remaining within expiry

Product: Midazolam HCl in 5% Dextrose

Model:

Recall #: D-0435-2018

Lot Numbers:

All lots remaining within expiry

Product: Morphine Sulfate in 0.9% Sodium Chloride

Model:

Recall #: D-0436-2018

Lot Numbers:

All lots remaining within expiry

Product: Morphine Sulfate in 5% Dextrose

Model:

Recall #: D-0437-2018

Lot Numbers:

All lots remaining within expiry

Product: Lidocaine HCl

Model:

Recall #: D-0438-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate in 0.9% Sodium Chloride

Model:

Recall #: D-0439-2018

Lot Numbers:

All lots remaining within expiry

Product: Potassium Chloride in 0.9% Sodium Chloride

Model:

Recall #: D-0440-2018

Lot Numbers:

All lots remaining within expiry

Product: Ketamine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0441-2018

Lot Numbers:

All lots remaining within expiry

Product: Succinylcholine Chloride

Model:

Recall #: D-0442-2018

Lot Numbers:

All lots remaining within expiry

Product: Adenosine Injection

Model:

Recall #: D-0443-2018

Lot Numbers:

All lots remaining within expiry

Product: Dexamethasone Sodium Phosphate

Model:

Recall #: D-0444-2018

Lot Numbers:

All lots remaining within expiry

Product: Phenylephrine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0445-2018

Lot Numbers:

All lots remaining within expiry

Product: Potassium Chloride in 5% Dextrose

Model:

Recall #: D-0446-2018

Lot Numbers:

All lots remaining within expiry

Product: Labetalol HCl

Model:

Recall #: D-0447-2018

Lot Numbers:

All lots remaining within expiry

Product: Methadone HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0448-2018

Lot Numbers:

All lots remaining within expiry

Product: Midazolam HCl Injection

Model:

Recall #: D-0449-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate Injection

Model:

Recall #: D-0450-2018

Lot Numbers:

All lots remaining within expiry

Product: Ephedrine Sulfate Injection

Model:

Recall #: D-0451-2018

Lot Numbers:

All lots remaining within expiry

Product: Ketamine HCl Injection

Model:

Recall #: D-0452-2018

Lot Numbers:

All lots remaining within expiry

Product: Ropivacaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0453-2018

Lot Numbers:

All lots remaining within expiry

Product: Glycopyrrolate

Model:

Recall #: D-0454-2018

Lot Numbers:

All lots remaining within expiry

Product: Lidocaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0455-2018

Lot Numbers:

All lots remaining within expiry

Product: Atropine Sulfate Injection

Model:

Recall #: D-0456-2018

Lot Numbers:

All lots remaining within expiry

Product: HYDROmorphone HCl in 5% Dextrose

Model:

Recall #: D-0457-2018

Lot Numbers:

All lots remaining within expiry

Product: Ropivacaine HCl Injection

Model:

Recall #: D-0458-2018

Lot Numbers:

All lots remaining within expiry

Product: Nicardipine HCl

Model:

Recall #: D-0459-2018

Lot Numbers:

All lots remaining within expiry

Product: Labetalol HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0460-2018

Lot Numbers:

All lots remaining within expiry

Product: Neostigmine Methylsulfate Injection

Model:

Recall #: D-0461-2018

Lot Numbers:

All lots remaining within expiry

Product: Vecuronium Bromide in Sterile Water for Injection

Model:

Recall #: D-0462-2018

Lot Numbers:

All lots remaining within expiry

Product: Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride

Model:

Recall #: D-0463-2018

Lot Numbers:

All lots remaining within expiry

Product: Esmolol HCl

Model:

Recall #: D-0464-2018

Lot Numbers:

All lots remaining within expiry

Product: Meperidine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0465-2018

Lot Numbers:

All lots remaining within expiry

Product: Methadone HCl Injection

Model:

Recall #: D-0466-2018

Lot Numbers:

All lots remaining within expiry

Product: Rocuronium Bromide

Model:

Recall #: D-0467-2018

Lot Numbers:

All lots remaining within expiry

Product: Dexamethasone Sodium Phosphate added to 5% Dextrose

Model:

Recall #: D-0468-2018

Lot Numbers:

All lots remaining within expiry

Product: Nicardipine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0469-2018

Lot Numbers:

All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78828

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Sold By: Hospitals; Clinics; Healthcare facilities

Manufactured In: United States

Units Affected: 42 products (Unknown; 297 bags; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown)

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 any of the 42 recalled medications from Pharmedium Services, LLC, which include various doses and strengths of drugs such as HYDROmorphone, Fentanyl, Morphine, Midazolam, Ketamine, and Lidocaine.

Check the medication packaging for the manufacturer name 'Pharmedium Services, LLC' and verify the recall number against the list of 42 affected products (ranging from D-0428-2018 to D-0469-2018).

Confirm if the product is 'within expiry,' as the recall includes all lots that have not yet reached their expiration date.

Immediately stop using the affected products and secure them to prevent further use in clinical settings.

Contact your healthcare provider or pharmacist immediately for guidance if you have been administered any of these medications and are experiencing unusual symptoms.

Return any unused recalled product to the pharmacy or place of purchase for a refund and contact Pharmedium Services, LLC for further instructions regarding the return process.

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

Affected Products

Product: HYDROmorphone HCl in Sodium Chloride 0.9%

Model:

Recall #: D-0428-2018

Lot Numbers:

All lots remaining within expiry

Product: Bupivacaine HCl in 0.9% Sodium Chloride (297 bags)

Model:

Recall #: D-0429-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0430-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0431-2018

Lot Numbers:

All lots remaining within expiry

Product: Ephedrine Sulfate in 0.9% Sodium Chloride

Model:

Recall #: D-0432-2018

Lot Numbers:

All lots remaining within expiry

Product: HYDROmorphone HCl Injection

Model:

Recall #: D-0433-2018

Lot Numbers:

All lots remaining within expiry

Product: Midazolam HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0434-2018

Lot Numbers:

All lots remaining within expiry

Product: Midazolam HCl in 5% Dextrose

Model:

Recall #: D-0435-2018

Lot Numbers:

All lots remaining within expiry

Product: Morphine Sulfate in 0.9% Sodium Chloride

Model:

Recall #: D-0436-2018

Lot Numbers:

All lots remaining within expiry

Product: Morphine Sulfate in 5% Dextrose

Model:

Recall #: D-0437-2018

Lot Numbers:

All lots remaining within expiry

Product: Lidocaine HCl

Model:

Recall #: D-0438-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate in 0.9% Sodium Chloride

Model:

Recall #: D-0439-2018

Lot Numbers:

All lots remaining within expiry

Product: Potassium Chloride in 0.9% Sodium Chloride

Model:

Recall #: D-0440-2018

Lot Numbers:

All lots remaining within expiry

Product: Ketamine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0441-2018

Lot Numbers:

All lots remaining within expiry

Product: Succinylcholine Chloride

Model:

Recall #: D-0442-2018

Lot Numbers:

All lots remaining within expiry

Product: Adenosine Injection

Model:

Recall #: D-0443-2018

Lot Numbers:

All lots remaining within expiry

Product: Dexamethasone Sodium Phosphate

Model:

Recall #: D-0444-2018

Lot Numbers:

All lots remaining within expiry

Product: Phenylephrine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0445-2018

Lot Numbers:

All lots remaining within expiry

Product: Potassium Chloride in 5% Dextrose

Model:

Recall #: D-0446-2018

Lot Numbers:

All lots remaining within expiry

Product: Labetalol HCl

Model:

Recall #: D-0447-2018

Lot Numbers:

All lots remaining within expiry

Product: Methadone HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0448-2018

Lot Numbers:

All lots remaining within expiry

Product: Midazolam HCl Injection

Model:

Recall #: D-0449-2018

Lot Numbers:

All lots remaining within expiry

Product: Fentanyl Citrate Injection

Model:

Recall #: D-0450-2018

Lot Numbers:

All lots remaining within expiry

Product: Ephedrine Sulfate Injection

Model:

Recall #: D-0451-2018

Lot Numbers:

All lots remaining within expiry

Product: Ketamine HCl Injection

Model:

Recall #: D-0452-2018

Lot Numbers:

All lots remaining within expiry

Product: Ropivacaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0453-2018

Lot Numbers:

All lots remaining within expiry

Product: Glycopyrrolate

Model:

Recall #: D-0454-2018

Lot Numbers:

All lots remaining within expiry

Product: Lidocaine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0455-2018

Lot Numbers:

All lots remaining within expiry

Product: Atropine Sulfate Injection

Model:

Recall #: D-0456-2018

Lot Numbers:

All lots remaining within expiry

Product: HYDROmorphone HCl in 5% Dextrose

Model:

Recall #: D-0457-2018

Lot Numbers:

All lots remaining within expiry

Product: Ropivacaine HCl Injection

Model:

Recall #: D-0458-2018

Lot Numbers:

All lots remaining within expiry

Product: Nicardipine HCl

Model:

Recall #: D-0459-2018

Lot Numbers:

All lots remaining within expiry

Product: Labetalol HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0460-2018

Lot Numbers:

All lots remaining within expiry

Product: Neostigmine Methylsulfate Injection

Model:

Recall #: D-0461-2018

Lot Numbers:

All lots remaining within expiry

Product: Vecuronium Bromide in Sterile Water for Injection

Model:

Recall #: D-0462-2018

Lot Numbers:

All lots remaining within expiry

Product: Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride

Model:

Recall #: D-0463-2018

Lot Numbers:

All lots remaining within expiry

Product: Esmolol HCl

Model:

Recall #: D-0464-2018

Lot Numbers:

All lots remaining within expiry

Product: Meperidine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0465-2018

Lot Numbers:

All lots remaining within expiry

Product: Methadone HCl Injection

Model:

Recall #: D-0466-2018

Lot Numbers:

All lots remaining within expiry

Product: Rocuronium Bromide

Model:

Recall #: D-0467-2018

Lot Numbers:

All lots remaining within expiry

Product: Dexamethasone Sodium Phosphate added to 5% Dextrose

Model:

Recall #: D-0468-2018

Lot Numbers:

All lots remaining within expiry

Product: Nicardipine HCl in 0.9% Sodium Chloride

Model:

Recall #: D-0469-2018

Lot Numbers:

All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78828

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Sold By: Hospitals; Clinics; Healthcare facilities

Manufactured In: United States

Distributed To: Nationwide