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Recall Observatory FDA recall evidence

Drug 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

D-0213-2018

January 09, 2017

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 78842
Status
Terminated
Classification
Class II
Quantity
1,051 vials
Official record key
drug-enforcement:D-0213-2018

Official wording

Reason: 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.

Code information: Lot #: H7044, Exp 05/19

Distribution pattern: Distributed nationwide in the USA, Uzbekistan, and Myanmar

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.