March 2014 FDA Recall Zoledronic Acid by Sagent Pharmaceuticals Inc
D-1615-2014 - Lack of Assurance of Sterility; leaking of premix bags

This Class II drug recall was voluntarily initiated by Sagent Pharmaceuticals Inc on March 4, 2014 for the product Zoledronic Acid. The FDA reported the reason for recall as lack of assurance of sterility; leaking of premix bags. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1615-2014

Reason for Recall
Lack of Assurance of Sterility; leaking of premix bags
Initiated
03-04-2014
Reported
10-08-2014
Quantity
10,622 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67689
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.
Sagent Pharmaceuticals 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-07-2016
Product Description About Product Description
Full technical description of the product.
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82

Batch or Lot Expiration Information

Lot# NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.

Affected Packages Involved in this Recall

25021-830-82 Zoledronic Acid
25021-830-87 Zoledronic Acid