February 2019 FDA Recall Drug by Amerigen Pharmaceuticals Inc.
D-0516-2019 - Failed dissolution specifications

This Class III drug recall was voluntarily initiated by Amerigen Pharmaceuticals Inc. on February 19, 2019 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States. and the recall is currently terminated.

Recall Number: D-0516-2019

Reason for Recall
Failed dissolution specifications
Initiated
02-19-2019
Reported
02-27-2019
Quantity
a) 2,413 bottles b) 3,355 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82158
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.
Amerigen Pharmaceuticals 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-17-2019
Product Description About Product Description
Full technical description of the product.
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071

Batch or Lot Expiration Information

Lot# : a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020