DOCETAXEL

Generic: DOCETAXEL

Baxter Healthcare CorporationManufacturer
INTRAVENOUSRoute
DOCETAXELActive Substance
2011-06-29Original Approval

DOCETAXEL is FDA application NDA201525, sponsored by SANDOZ. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2019-03-06
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited

Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility a

Class II2018-04-27
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been

Class I2024-05-28
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceu

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Class I2024-05-28
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceutic

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Class II2017-01-09
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatn

Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vi

Top Reported Reactions

1
ALOPECIA
16,970 reports
2
MADAROSIS
6,717 reports
3
HAIR TEXTURE ABNORMAL
5,993 reports
4
HAIR COLOUR CHANGES
5,874 reports
5
HAIR DISORDER
5,625 reports
6
DIARRHOEA
5,242 reports
7
NAUSEA
3,815 reports
8
EMOTIONAL DISTRESS
3,615 reports
9
ANXIETY
3,456 reports
10
NEUTROPENIA
3,371 reports