Drug 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.
D-1001-2019
Product summary
- Event
- Event 82323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,755 vials
- Official record key
drug-enforcement:D-1001-2019
Official wording
Reason: Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Code information: Lot#: H7081, Exp 07/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
lack of sterility