Docetaxel Injection, Solution
FDA Recall NDC 43598-259
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Docetaxel (NDC 43598-259). A significant event, classified as Class II, was initiated on Mar 06, 2019 by Dr. Reddy's Laboratories Inc.. The reported reason for this action was: "Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Mar 06, 2019
Mar 20, 2019
5,755 vials
Recall Profile & Regulatory Data
Event ID
82323
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 16, 2022
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.
Batch or Lot Expiration Information
Lot# : H7081, Exp 07/2019
Affected Packages Involved in this Recall
43598-258-11Product
43598-259-40Product
43598-389-57Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
