Docetaxel Injection Recalled Due to Particulate Matter in Stopper
Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper. Lot F1040001 was 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls warrant a minimum severity score of 4 (Severe), regardless of whether illnesses have been reported. No illnesses or injuries are documented in the source.
Plain-English summary
Sagent Pharmaceuticals is recalling Docetaxel Injection, USP (80 mg per 8 mL) due to the presence of particulate matter from the vial stopper. The affected lot is F1040001 (expiration date 12/31/2024), comprising 762 vials that were distributed nationwide.
Docetaxel is a chemotherapy drug administered by intravenous injection. Patients who received doses from this lot should inform their healthcare provider of the recall.
Healthcare facilities with inventory from lot F1040001 should stop dispensing and contact the FDA for guidance on returning the product.
The recalled product
- Product
- DOCETAXEL (DOCETAXEL ANHYDROUS)
- Brand
- DOCETAXEL
- Manufacturer
- Sagent Pharmaceuticals
- Category
- Drug — Injectable / Chemotherapy
- Hazard
- Affected units
- 762
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 #: F1040001
- 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
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Same hazard · particulate matter
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Similar recalls
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FDA (Drugs) · 2018-01-17
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