Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: Fentanyl Citrate Prefilled Syringes Recalled for Subpotency

Agency Publication Date: June 25, 2018

Summary

Advanced Pharma Inc. has recalled 100 syringes of Fentanyl Citrate USP (5 mcg in 0.9% Sodium Chloride USP, 0.5 mL) because the medication is subpotent, meaning the drug concentration is lower than what is indicated on the label. This recall affects 100 prefilled syringes that were distributed to a single medical center in Fort Worth, Texas. Because the drug is less powerful than expected, patients may not receive the intended therapeutic dose, which can lead to inadequate pain management. Patients who received this medication should contact their healthcare provider or pharmacist.

Risk

The drug's concentration is lower than labeled, which may result in patients receiving a lower dose than prescribed, leading to ineffective treatment and uncontrolled pain.

What You Should Do

Identify the affected product by checking the label for 'fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe' with NDC 15082-210-72.
Check the packaging for Lot Number 6/12/18 0432 149-21072S and a Beyond Use Date (BUD) of 9/10/18.
If you have this product, stop using it immediately and do not administer it to patients.
Contact your healthcare provider or pharmacist immediately for guidance if you have been treated with this medication.
Return any unused syringes to the place of purchase for a refund and contact Advanced Pharma Inc. at 9265 Kirby Dr, Houston, TX 77054 for further instructions.
For additional questions, 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: fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe (0.5 mL)

Model:

NDC 15082-210-72

Lot Numbers:

6/12/18 0432 149-21072S

Date Ranges: 9/10/18 (Beyond Use Date)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80354

Status: Resolved

Manufacturer: Advanced Pharma Inc.

Sold By: Medical center in Fort Worth, TX

Manufactured In: United States

Units Affected: 100 syringes

Distributed To: Texas

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 the affected product by checking the label for 'fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe' with NDC 15082-210-72.

Check the packaging for Lot Number 6/12/18 0432 149-21072S and a Beyond Use Date (BUD) of 9/10/18.

If you have this product, stop using it immediately and do not administer it to patients.

Contact your healthcare provider or pharmacist immediately for guidance if you have been treated with this medication.

Return any unused syringes to the place of purchase for a refund and contact Advanced Pharma Inc. at 9265 Kirby Dr, Houston, TX 77054 for further instructions.

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