Medications & Supplements/Prescription Drugs

Pharmedium Services, LLC: Fentanyl and Ropivacaine Injections Recalled for Sub-potency

Agency Publication Date: December 14, 2018

Summary

Pharmedium Services, LLC has recalled 590 units of Fentanyl Citrate and Ropivacaine HCl injections, which are used for pain management, because they were found to be sub-potent. This means the medication may contain less of the active drug than intended, which could lead to inadequate pain control for patients during medical procedures. The recall affects 50 mL syringes and 100 mL Intravia bags distributed nationwide in the United States. No specific incidents or injuries were reported in the recall data, but the company initiated this voluntary recall after discovering the potency issue.

Risk

The medication is sub-potent, meaning it provides a lower dose of pain relief than prescribed. This can result in patients experiencing uncontrolled pain or requiring additional medical intervention during surgery or recovery.

What You Should Do

Check your medical supplies for Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.1% in 50 mL BD Syringes (NDC 61553-644-75) with lot number 183220013C and expiration date 12/19/2018.
Check your medical supplies for Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.2% in 100 mL Intravia Bags (NDC 61553-148-48) with lot number 183230004C and expiration date 02/17/2019.
Immediately stop using any products that match the affected lot numbers and NDC codes listed above.
Contact your healthcare provider or pharmacist for guidance regarding alternative treatments if you believe you have been administered these products.
Return any unused recalled product to the pharmacy or place of purchase for a refund and contact Pharmedium Services, LLC at 1-888-723-3332 for further instructions.
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

Product return and refund

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

Affected Products

Product: Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.1% Injection (50 mL)

Model:

NDC 61553-644-75

D-0333-2019

Lot Numbers:

183220013C (Exp. 12/19/2018)

Date Ranges: Expires 12/19/2018

Product: Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.2% Injection (100 mL)

Model:

NDC 61553-148-48

D-0334-2019

Lot Numbers:

183230004C (Exp. 02/17/2019)

Date Ranges: Expires 02/17/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81730

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Sold By: Hospitals; Surgical centers

Manufactured In: United States

Units Affected: 2 products (295 50 ml in 60 ml syringes; 295 100 mL in 150 mL Intravia bags)

Distributed To: Nationwide

Agency Last Updated: December 20, 2018

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 Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.1% in 50 mL BD Syringes (NDC 61553-644-75) with lot number 183220013C and expiration date 12/19/2018.

Check your medical supplies for Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.2% in 100 mL Intravia Bags (NDC 61553-148-48) with lot number 183230004C and expiration date 02/17/2019.

Immediately stop using any products that match the affected lot numbers and NDC codes listed above.

Contact your healthcare provider or pharmacist for guidance regarding alternative treatments if you believe you have been administered these products.

Return any unused recalled product to the pharmacy or place of purchase for a refund and contact Pharmedium Services, LLC at 1-888-723-3332 for further instructions.

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: Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.1% Injection (50 mL)

Model:

NDC 61553-644-75

D-0333-2019

Lot Numbers:

183220013C (Exp. 12/19/2018)

Date Ranges: Expires 12/19/2018

Product: Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.2% Injection (100 mL)

Model:

NDC 61553-148-48

D-0334-2019

Lot Numbers:

183230004C (Exp. 02/17/2019)

Date Ranges: Expires 02/17/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81730

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Sold By: Hospitals; Surgical centers

Manufactured In: United States

Units Affected: 2 products (295 50 ml in 60 ml syringes; 295 100 mL in 150 mL Intravia bags)

Distributed To: Nationwide

Agency Last Updated: December 20, 2018