November 2017 FDA Recall Drug by Elite Laboratories Inc.
D-0107-2018 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Elite Laboratories Inc. on November 13, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in NY only and the recall is currently terminated.

Recall Number: D-0107-2018

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
11-13-2017
Reported
12-13-2017
Quantity
1264 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78502
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.
Elite Laboratories 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-15-2019
Product Description About Product Description
Full technical description of the product.
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013

Batch or Lot Expiration Information

Lot# : P0910-017, Exp. 05/2019