Medications & Supplements/Prescription Drugs

PharMedium Services, Llc: Fentanyl Citrate Recalled for Incorrect Expiration Date Labeling

Agency Publication Date: September 15, 2017

Summary

PharMedium Services, LLC is recalling 885 bags of compounded Fentanyl Citrate (Preservative Free) because the liquid used to mix the medication expired before the expiration date printed on the final product label. This recall includes Fentanyl Citrate 10 mcg per mL (590 bags) and 20 mcg per mL (295 bags) solutions. Because the diluent expired early, the medication may not maintain its required stability or potency through the date listed on the bag. Consumers should contact their healthcare provider or pharmacist regarding these products.

Risk

The use of an expired diluent means the medication might not meet its quality and potency standards before the expiration date shown on the label, potentially affecting the effectiveness of the treatment.

What You Should Do

Identify if you have the 10 mcg per mL (1,000 mcg per 100 mL) version by checking for NDC 61553-112-52 and lot numbers 170850012C or 170850020C with an expiration date of 06/25/17.
Identify if you have the 20 mcg per mL (2,000 mcg per 100 mL) version by checking for NDC 61553-605-52 and lot number 170850021C with an expiration date of 06/25/17.
Immediately contact your healthcare provider or pharmacist for guidance if you are in possession of these specific medication bags.
Return any unused or remaining medication bags to the pharmacy or place of purchase for a refund.
Contact the manufacturer, PharMedium Services, LLC, for further instructions regarding this recall.
For additional questions or to report a problem, 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 or pharmacist; return unused product to pharmacy 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: Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) in Sodium Chloride 0.9%

Model:

NDC 61553-112-52

Recall #: D-1165-2017

Lot Numbers:

170850012C (Exp. 06/25/17)

170850020C (Exp. 06/25/17)

Date Ranges: Expiration date 06/25/17

Product: Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) in Sodium Chloride 0.9%

Model:

NDC 61553-605-52

Recall #: D-1166-2017

Lot Numbers:

170850021C (Exp. 06/25/17)

Date Ranges: Expiration date 06/25/17

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77856

Status: Resolved

Manufacturer: PharMedium Services, Llc

Sold By: hospitals; clinics

Manufactured In: United States

Units Affected: 2 products (590 bags; 295 bags)

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 10 mcg per mL (1,000 mcg per 100 mL) version by checking for NDC 61553-112-52 and lot numbers 170850012C or 170850020C with an expiration date of 06/25/17.

Identify if you have the 20 mcg per mL (2,000 mcg per 100 mL) version by checking for NDC 61553-605-52 and lot number 170850021C with an expiration date of 06/25/17.

Immediately contact your healthcare provider or pharmacist for guidance if you are in possession of these specific medication bags.

Return any unused or remaining medication bags to the pharmacy or place of purchase for a refund.

Contact the manufacturer, PharMedium Services, LLC, for further instructions regarding this recall.

For additional questions or to report a problem, 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 (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) in Sodium Chloride 0.9%

Model:

NDC 61553-112-52

Recall #: D-1165-2017

Lot Numbers:

170850012C (Exp. 06/25/17)

170850020C (Exp. 06/25/17)

Date Ranges: Expiration date 06/25/17

Product: Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) in Sodium Chloride 0.9%

Model:

NDC 61553-605-52

Recall #: D-1166-2017

Lot Numbers:

170850021C (Exp. 06/25/17)

Date Ranges: Expiration date 06/25/17