October 2018 FDA Recall Drug by Amerigen Pharmaceuticals Inc.
D-0249-2019 - Failed dissolution specifications

This Class III drug recall was voluntarily initiated by Amerigen Pharmaceuticals Inc. on October 5, 2018 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0249-2019

Reason for Recall
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Initiated
10-05-2018
Reported
10-24-2018
Quantity
5,232 bottles: a) 4,146 bottles; b) 1,086 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81189
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 U.S. nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2019
Product Description About Product Description
Full technical description of the product.
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.

Batch or Lot Expiration Information

Lot# : a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19