Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Docetaxel Injection (Docetaxel Anhydrous)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Affected NDC
25021-0254-08
Compare with the code on your package — it is the most precise check available.
Drug: Docetaxel
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Docetaxel Docetaxel Anhydrous NDC 25021-0254 |
10 mg/mL | Injection Intravenous |
Sagent Pharmaceuticals | Rx |
- Recalling firm
- Sagent Pharmaceuticals
- NDC code
- 25021-254-08
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- May 28, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0554-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Docetaxel recalls
See all
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
DOCETAXEL 60 MG / 250 ml D5W IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Docetaxel Injection USP
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class II · Moderate risk
Docetaxel injection concentrate
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Other recalls by Sagent Pharmaceuticals
All 2024 recalls
Class III · Low risk
Busulfan Injection
Failed Impurities/Degradation Specifications
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
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