FDA-Drug2019-03-20Class II

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.

Dr. Reddy's Laboratories, Inc.
Hazard

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

Sold states
Nationwide in the USA
Affected count
5,755 vials
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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.

Official notice

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

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