D-1001-2019 Class II Terminated
FDA drug recall D-1001-2019 was initiated by Dr. Reddy's Laboratories, Inc. on March 6, 2019 and is designated Class II. Reason for recall: Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance. The recall status is terminated (terminated May 16, 2022). Affected quantity: 5,755 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2019
- Initiation Date
- March 6, 2019
- Termination Date
- May 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,755 vials
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: H7081, Exp 07/2019