December 2016 FDA Recall Fluconazole by Baxter Healthcare Corporation
D-0206-2017 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on December 6, 2016 for the product Fluconazole. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in United States, United Arab Emirates, and Colombia and the recall is currently terminated.

Recall Number: D-0206-2017

Reason for Recall
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Initiated
12-06-2016
Reported
12-28-2016
Quantity
30,910 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75831
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.
Baxter Healthcare Corporation
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.
United States, United Arab Emirates, and Colombia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-12-2018
Product Description About Product Description
Full technical description of the product.
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.

Batch or Lot Expiration Information

Lot# : P344028 on bags, P344028A on shipping container, Exp 12/31/2017

Affected Packages Involved in this Recall

0338-6046-48 Fluconazole
0338-6045-37 Fluconazole