Elevated risk U.S. Food and Drug Administration

Sagent Docetaxel Injection, USP recall: Potential presence of particulate matter

Recall published 2+ years ago

Potential presence of particulate matter

Sagent Veterinary drugs — recalled veterinary drugsSagent Veterinary drugs — recalled veterinary drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
May 28, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Sagent
Product type
Veterinary drugs
Distribution
Nationwide

Products covered by this recall

Docetaxel Injection, USP

What the company announced

FOR IMMEDIATE RELEASE - SCHAUMBURG, IL – May 28, 2024 – Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product.

Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications related to injection of particles include inflammation of a vein, granuloma, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.

To date, Sagent Pharmaceuticals has not received any reports of adverse events related to this recall.

The Docetaxel Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. Product was distributed Nationwide from October 11, 2023, to April 11, 2024.

  • Product: DOCETAXEL INJECTION, USP · Lot Number: F1030001 F1040001 · NDC: 25021-254-16 25021-254-08 · Expiration Date: 12/2024 12/2024 · Strength: 160 mg/16 mL (10 mg/mL) 80 mg/8 mL (10 mg/mL)

Customers are being notified by a FedEx package that includes arrangements for return of all recalled product. Customers are instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots listed above. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com .

Customers with any questions about returning unused product are directed to the customer call center at (866) 625-1618 M-F, 8am-5pm CST, option 1. Healthcare workers who have medical questions about Docetaxel Injection, USP, may contact Medical Affairs (866) 625-1618, Option 3, M-F, 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • F1030001 F1040001

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12/2024 12/2024

NDC number

On the carton and again on the bottle or blister label.

  • 25021-254-16

Package size

Match the net weight or the piece count on the front of the pack.

  • 80 mg
  • 8 mL
  • 160 mg
  • 16 mL
  • 10 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Sagent — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Sagent Pharmaceuticals — Consumers: Customer Call Center, (866) 625-1618 Option 1

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Sagent veterinary drugs recalled?

Potential presence of particulate matter Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code F1030001 F1040001; best-by date 12/2024 12/2024. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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