FDA-Drug2018-01-17Class II

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

Dr. Reddy's Laboratories, Inc.
Hazard

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.

Sold states
Distributed nationwide in the USA, Uzbekistan, and Myanmar
Affected count
1,051 vials
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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

Official notice

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

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