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FDAFDA · Food and drugs·Recall number D-1001-2019

Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.

Published March 20, 2019 · Recall initiated: March 6, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
DOCETAXEL
Manufacturer
Dr. Reddy's Laboratories, Inc.
Distributor
Nationwide in the USA
Lot
Lot#: H7081, Exp 07/2019
Risk classification
Class II
Area (FDA)
drug
Country
United States

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