Recall: D-1001-2019

Class II - Potentially Harmful

Class IIClassification

2019-03-06Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

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.

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.