FDA recall D-1001-2019

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-03-06

Report date

2019-03-20

Termination date

2022-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1001-2019