The Recall Desk
LowFDA (Drugs)·D-0345-2019·Announced 2019-01-02

Amerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications

Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Amerigen Pharmaceuticals Inc. is recalling Temozolomide Capsules, 180 mg, packaged in 14-count bottles. The product is manufactured by Stason Pharmaceuticals, Inc., and distributed by Amerigen Pharmaceuticals. The specific lot number is 18E031, with an expiration date of 05/2020. The recall involves 771 bottles.

The recall was initiated because the product failed dissolution specifications. Dissolution tests ensure that the medication releases the active ingredient at the correct rate; failure to meet these specifications may result in the medication not working as intended. The FDA has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences.

The product was distributed to four wholesalers and two retail accounts, which may have further distributed the medication. Patients and healthcare providers should check their inventory for the specific NDC 43975-256-14 and Lot # 18E031. If the product is found, it should be returned to the pharmacy or contact Amerigen Pharmaceuticals for further instructions.

The recalled product

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
Manufacturer
Amerigen Pharmaceuticals Inc.
Category
Drug — Oncology
Hazard
Affected units
771

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 18E031
  • exp 05/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Amerigen Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Amerigen Pharmaceuticals Inc.

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Same hazard · failed dissolution

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