Recall: D-0213-2018

Class II - Potentially Harmful

Class IIClassification

2017-01-09Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11

Reason

Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.

Distribution

Distributed nationwide in the USA, Uzbekistan, and Myanmar

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