January 2017 FDA Recall Docetaxel by Dr. Reddy's Laboratories, Inc.
D-0213-2018 - Defective Container

This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on January 9, 2017 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-0213-2018

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.
Initiated
01-09-2017
Reported
01-17-2018
Quantity
1,051 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78842
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed nationwide in the USA, Uzbekistan, and Myanmar
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : H7044, Exp 05/19

Affected Packages Involved in this Recall

43598-611-11 Docetaxel
43598-610-40 Docetaxel