The Recall Desk
ModerateFDA (Drugs)·D-0344-2019·Announced 2019-01-02

Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

Amerigen Pharmaceuticals is recalling specific lots of Temozolomide Capsules because they failed to meet dissolution specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the hazard involves a failure to meet specifications rather than a direct physical injury risk.

Plain-English summary

Amerigen Pharmaceuticals Inc. is recalling 3,552 bottles of Temozolomide Capsules, 20 mg. The affected products are packaged in 5-count and 14-count bottles and were manufactured by Stason Pharmaceuticals, Inc. The specific lots involved are 18B005 A and 18B005 B, with an expiration date of 02/2020.

The recall was initiated because the product failed to meet dissolution specifications. This means the capsules may not release the medication in the body as intended, potentially affecting the drug's effectiveness.

The product was distributed to four wholesalers and two retail accounts, which may have further distributed the items. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if found.

The recalled product

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
Manufacturer
Amerigen Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
3,552

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)

  • a) Lot # 18B005 A and b) Lot # 18B005 B
  • exp 02/2020

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 →

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