Drug recall D-1001-2019

Class II Terminated reported Mar 20, 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.

Lots and codes

Lot#: H7081, Exp 07/2019

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
5,755 vials
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
March 6, 2019
Terminated
May 16, 2022

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