Multi-event December 2018 FDA Recall Drug by Amerigen Pharmaceuticals Inc.
This Multi-event Class III drug recall was voluntarily initiated by Amerigen Pharmaceuticals Inc. on December 20, 2018 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 and 2 retail accounts who may have further distributed the products. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0345-2019
Failed Dissolution Specifications
12-20-2018
01-02-2019
771 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
12-17-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
Batch or Lot Expiration Information
Lot# 18E031, exp 05/2020
Recall Number: D-0344-2019
Failed Dissolution Specifications
12-20-2018
01-02-2019
3552 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
12-17-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
Batch or Lot Expiration Information
Lot# a)
Lot# 18B005 A and b)
Lot# 18B005 B, exp 02/2020
