D-0213-2018 Class II Terminated
FDA drug recall D-0213-2018 was initiated by Dr. Reddy's Laboratories, Inc. on January 9, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 4, 2018). Affected quantity: 1,051 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2018
- Initiation Date
- January 9, 2017
- Termination Date
- December 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,051 vials
Product Description
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
Reason for Recall
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.
Distribution Pattern
Distributed nationwide in the USA, Uzbekistan, and Myanmar
Code Information
Lot #: H7044, Exp 05/19