Docetaxel Injection Recalled Nationwide for Stopper Particulate Matter
Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper contaminating the drug. The recall affects 2,806 vials distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification mandates Critical severity per the recall rubric. Particulate matter contaminating an intravenous chemotherapy drug represents a direct hazard to patient safety.
Plain-English summary
Sagent Pharmaceuticals is recalling Docetaxel Injection, USP, 160 mg per 16 mL (Lot F1030001, expiration 12/31/2024) nationwide due to the presence of particulate matter derived from the vial stopper. Docetaxel is a chemotherapy drug administered intravenously to treat cancer.
The contamination poses a direct hazard when the drug is administered, as particulate matter could be injected into the patient's bloodstream.
2,806 vials of the affected lot have been distributed throughout the United States under NDC 25021-254-08. Healthcare providers should not administer remaining doses from this lot. Healthcare professionals and patients with questions should contact Sagent Pharmaceuticals or their healthcare provider regarding unused doses.
The recalled product
- Product
- DOCETAXEL (DOCETAXEL ANHYDROUS)
- Brand
- DOCETAXEL
- Manufacturer
- Sagent Pharmaceuticals
- Category
- Drug — Injectable / Chemotherapy
- Hazard
- particulate-matter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: F1030001
- Exp. Date 12/31/2024
Distribution
Distributed nationwide across the United States.
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