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Drug FDA Class I Ongoing Foreign material

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Sagent Pharmaceuticals Published Jun 19, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Sagent Pharmaceuticals or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Hazards

Particulate Matter from Stopper · primary

Affected products (1)

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

DOCETAXEL · 762 vials

NDC: 25021-254, 25021-254-08, 25021-254-16
Code info: Lot #: F1040001, Exp. Date 12/31/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    May 28, 2024
  2. Published
    Jun 19, 2024
Recall number
D-0553-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.