FDA Recall of Chemotherapy Drug - MedWaste Management FDA Recall of Chemotherapy Drug - MedWaste Management

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Sagent Drug FDA recall Docetaxel

FDA Recall of Chemotherapy Drug

This week, the FDA announced an urgent recall of a chemotherapy drug used in the treatment of multiple types of tumors. The drug, administered intravenously, may contain particulate matter and could lead to serious health events for patients already at high risk for complications.

The drug, Docetaxel, is administered by healthcare providers. Therefore, all providers who keep this medication in stock must examine each package and ensure it is not included in the recall before administration. Patients can advocate for healthcare providers to compare each package to the recall information below before accepting the injection.

As of the writing of this notice, the FDA has not announced any adverse events related to the contamination.

SUMMARY

Date of Recall:

Announced: May 28, 2024

Public Notification: May 29, 2024

Name(s) of Drug:

Docetaxel Injection, USP (80mg per 8mL multi-dose vials and 160mg per 16mL multi-dose vials)

Company Name:

Sagent Pharmaceuticals

Drug Indication:

Tumor treatment/Chemotherapy

Sagent FDA Drug Recall Docetaxel
Sagent FDA Drug Recall Docetaxel

Product Description

Docetaxel is available by prescription only and is administered by healthcare providers, most often within the confines of a healthcare facility.

The vial’s blue or brown packages each contain the corresponding dosage and bear the manufacturer’s name on the back.

Reason for Recall

Sagent Pharmaceuticals received a customer report stating that the stopper in the vial caused particulate matter to accumulate. This matter may lead to serious health outcomes for patients who receive the medication, so Sagent initiated the recall out of an abundance of caution.

Impacts

Consumers who receive an infusion of medication that contains particulate matter are at high risk for serious health outcomes. Serious potential complications can include:

  • Vein Inflammation
  • Granuloma (clusters of white blood cells)
  • Blood clots
  • Stroke
  • Death

Recall Lot Information

All medical facilities and distributors who stock Docetaxel must carefully examine their inventory to determine if their product is included in the recall. Compare each vial’s NDC and lot numbers, strength, and expiration date to the chart below. If you find any matches, read further for instructions on participating in the recall.

ProductLot NumberNDCExpiration DateStrength
DOCETAXEL
INJECTION, USP
F1030001
 
F1040001
25021-254-16
 
25021-254-08
12/2024
 
12/2024
160 mg/16 mL
(10 mg/mL)
 
80 mg/8 mL
(10 mg/mL)
FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

If you find that your lot of medication is part of this recall, do the following:

  1. Do not allow the administration of a medication listed on the recall.
  2. Ask your doctor to replace the recalled injection with another that is not recalled. If the lot number, NDC number, and expiration date do not match the chart, the same medication may be used.
  3. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.

Healthcare Systems

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. If you have questions, contact Sagent Pharmaceuticals at 1-866-625-1618. They are available from 8 a.m. to 5 p.m. CST, Monday through Friday.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. If you have questions, contact Sagent Pharmaceuticals at 1-866-625-1618. They are available from 8 a.m. to 5 p.m. CST, Monday through Friday. Notify them of any recalled batches that have already been shipped to medical facilities.
  3. Notify affected medical facilities of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics.

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