FDAFDA · Food and drugs·Recall number D-0554-2024
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
Published June 19, 2024 · Recall initiated: May 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- DOCETAXEL
- Manufacturer
- Sagent Pharmaceuticals
- Distributor
- Nationwide within the USA.
- Lot
- Lot #: F1030001, Exp. Date 12/31/2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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