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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 2,806
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.
Part of a larger recall action
This product is one of 2 recalled by Sagent Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · DOCETAXEL
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Same hazard · particulate matter
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Similar recalls
- SevereSanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide
FDA (Drugs) · 2018-05-09
- ModerateDr. Reddy's Recalls Docetaxel Injection Vials Due to Seal Defects
FDA (Drugs) · 2018-01-17
- ModerateSagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter
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- SevereDr. Reddy's Recalls Docetaxel Injection Due to Vial Seal and Cap Defects
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- SevereShilpa Medicare Recalls Docetaxel Injection Due to Manufacturing Deviations
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