Medications & Supplements/Prescription Drugs

Amneal Pharmaceuticals LLC: Fosphenytoin Sodium Injection Recalled for Presence of Particulate Matter

Agency Publication Date: November 13, 2017

Summary

Amneal Pharmaceuticals LLC has recalled 14,000 vials of Fosphenytoin Sodium Injection, USP (500 mg PE/10 mL). This prescription medication, used for treating seizures, is being recalled because visible particles were found inside the vials. Injecting a medication containing particulate matter can cause serious health complications, such as local irritation, swelling, or the blocking of blood vessels, which can lead to organ damage.

Risk

The presence of solid particles in an injectable drug can cause inflammation or blockages in the bloodstream. If these particles travel through the circulatory system, they may cause a stroke, heart attack, or damage to the lungs and other vital organs.

What You Should Do

Check your medication to see if it matches Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL) in a 10 mL Single Dose Vial.
Locate the lot number and expiration date on the vial label to confirm if it is part of the affected batch: Lot # AP160016 with an expiration date of 05/18 (May 2018).
Confirm the NDC (National Drug Code) on the packaging is 70121-1390-7.
If you have this specific lot, stop using it immediately and do not administer the injection.
Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any concerns.
Return any unused product to the pharmacy or place of purchase for a refund and contact Amneal Pharmaceuticals for further instructions on returning the affected vials.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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: Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL)

Model:

NDC: 70121-1390-7

Recall #: D-0076-2018

Lot Numbers:

AP160016 (Exp. 05/18)

Date Ranges: 05/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78035

Status: Resolved

Manufacturer: Amneal Pharmaceuticals LLC

Sold By: Amneal Biosciences

Manufactured In: United States

Units Affected: 14,000 vials

Distributed To: Mississippi, North Carolina, Ohio, Texas, Utah

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 medication to see if it matches Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL) in a 10 mL Single Dose Vial.

Locate the lot number and expiration date on the vial label to confirm if it is part of the affected batch: Lot # AP160016 with an expiration date of 05/18 (May 2018).

Confirm the NDC (National Drug Code) on the packaging is 70121-1390-7.

If you have this specific lot, stop using it immediately and do not administer the injection.

Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any concerns.

Return any unused product to the pharmacy or place of purchase for a refund and contact Amneal Pharmaceuticals for further instructions on returning the affected vials.

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