March 2016 FDA Recall Zoledronic Acid by Dr. Reddy's Laboratories, Inc.
D-0784-2016 - Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on March 3, 2016 for the product Zoledronic Acid. The FDA reported the reason for recall as lack of assurance of sterility; defective seals where the metal silver ring was not attached tightly to the vial. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0784-2016

Reason for Recall
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Initiated
03-03-2016
Reported
04-06-2016
Quantity
3,342 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73527
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-03-2017
Product Description About Product Description
Full technical description of the product.
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52

Batch or Lot Expiration Information

Lot# Lot BS523, exp 10/2017

Affected Packages Involved in this Recall

55111-688-52 Zoledronic Acid