Medications & Supplements/Prescription Drugs

Docetaxel Injection Recalled for Potential Particulate Matter Contamination

Agency Publication Date: June 12, 2024

Summary

Sagent Pharmaceuticals is recalling 3,568 vials of Docetaxel Injection, USP (80 mg per 8 mL and 160 mg per 16 mL) because pieces of the vial stopper may be present in the medication. This recall affects two specific lots of the drug, which is a chemotherapy medication administered by healthcare professionals in clinical settings. Patients who have concerns about a recent treatment should contact their healthcare provider.

Risk

If stopper particles are injected into the bloodstream, they can cause serious health complications including blood clots (embolism), inflammation, organ damage, or other life-threatening reactions. No injuries or adverse events have been reported to date.

What You Should Do

This recall affects 8 mL (80 mg) and 16 mL (160 mg) multi-dose vials of Docetaxel Injection, USP manufactured for Sagent Pharmaceuticals.
Identify the affected medication by checking the vial labels for NDC 25021-254-08 (80 mg) with lot F1040001, or NDC 25021-254-16 (160 mg) with lot F1030001. Both affected lots have an expiration date of 12/31/2024.
Stop using the recalled product immediately. Contact Sagent Pharmaceuticals or your medical distributor to arrange for the return of all unused vials.
Healthcare providers should quarantine any remaining inventory from these lots and notify any patients who may have received the affected product.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Docetaxel Injection, USP (80 mg per 8 mL)

Variants: 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial

Lot Numbers:

F1040001 (Exp 12/31/2024)

NDC:

25021-254-08

Manufactured in India for Sagent Pharmaceuticals. Recall #: D-0553-2024.

Product: Docetaxel Injection, USP (160 mg per 16 mL)

Variants: 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial

Lot Numbers:

F1030001 (Exp 12/31/2024)

NDC:

25021-254-16

Manufactured in India for Sagent Pharmaceuticals. Recall #: D-0554-2024.

Product Images

Image 1 – Labeling, Docetaxel, 160mg per 16 mL

Image 2 – Labeling, Docetaxel, 80 mg per 8 ml

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94707

Status: Active

Manufacturer: Sagent Pharmaceuticals

Sold By: Hospitals; Infusion Centers; Oncology Clinics; Medical Wholesalers

Manufactured In: India

Units Affected: 2 products (762 vials; 2806 vials)

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 · FDA Press Release · 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

This recall affects 8 mL (80 mg) and 16 mL (160 mg) multi-dose vials of Docetaxel Injection, USP manufactured for Sagent Pharmaceuticals.

Identify the affected medication by checking the vial labels for NDC 25021-254-08 (80 mg) with lot F1040001, or NDC 25021-254-16 (160 mg) with lot F1030001. Both affected lots have an expiration date of 12/31/2024.

Stop using the recalled product immediately. Contact Sagent Pharmaceuticals or your medical distributor to arrange for the return of all unused vials.

Healthcare providers should quarantine any remaining inventory from these lots and notify any patients who may have received the affected product.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Docetaxel Injection, USP (80 mg per 8 mL)

Variants: 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial

Lot Numbers:

F1040001 (Exp 12/31/2024)

NDC:

25021-254-08

Manufactured in India for Sagent Pharmaceuticals. Recall #: D-0553-2024.

Product: Docetaxel Injection, USP (160 mg per 16 mL)

Variants: 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial

Lot Numbers:

F1030001 (Exp 12/31/2024)

NDC:

25021-254-16

Manufactured in India for Sagent Pharmaceuticals. Recall #: D-0554-2024.