November 2017 FDA Recall Drug by Renaissance Lakewood, Llc
D-0124-2018 - Superpotent

This Class III drug recall was voluntarily initiated by Renaissance Lakewood, Llc on November 11, 2017 for the product Drug. The FDA reported the reason for recall as superpotent. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0124-2018

Reason for Recall
Superpotent
Initiated
11-11-2017
Reported
12-27-2017
Quantity
24,569 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78504
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.
04-01-2020
Product Description About Product Description
Full technical description of the product.
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

Batch or Lot Expiration Information

Lot# a) A060174 01/13/2018, A060257 02/28/2018, A060692 05/31/2018, A061165 09/30/2018, A0A0143 01/31/2019, A0A0347 03/31/2019, and A0A0424 04/30/2019 ; b) A060027 12/31/2017