FDA recall D-0213-2018

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 for recall

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

Key facts

Status

Terminated

Initiation date

2017-01-09

Report date

2018-01-17

Termination date

2018-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2018