February 2018 FDA Recall Drug by Renaissance Lakewood, Llc
D-0696-2018 - Labeling

This Class II drug recall was voluntarily initiated by Renaissance Lakewood, Llc on February 21, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.

Recall Number: D-0696-2018

Reason for Recall
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Initiated
02-21-2018
Reported
04-25-2018
Quantity
1784 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79580
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.
Renaissance Lakewood, LLC
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.
Product was distributed throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2019
Product Description About Product Description
Full technical description of the product.
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10

Batch or Lot Expiration Information

Lot# : A0A0539, Exp. 05/19