March 2019 FDA Recall Docetaxel by Dr. Reddy's Laboratories, Inc.
D-1001-2019 - Defective Container
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on March 6, 2019 for the product Docetaxel. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1001-2019
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
03-06-2019
03-20-2019
5,755 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
05-16-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : H7081, Exp 07/2019
