March 2018 FDA Recall Drug by Renaissance Lakewood, Llc
D-0605-2018 - Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability

This Class III drug recall was voluntarily initiated by Renaissance Lakewood, Llc on March 2, 2018 for the product Drug. The FDA reported the reason for recall as superpotent and failed stability specifications; out of specification results for assay and water vapor permeability. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0605-2018

Reason for Recall
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Initiated
03-02-2018
Reported
04-04-2018
Quantity
1277 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79310
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2020
Product Description About Product Description
Full technical description of the product.
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10

Batch or Lot Expiration Information

Lot# Lot A060644, May 2018