Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures
Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA 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, 5 mg, in 5-count and 14-count bottles. The recall was initiated because the product failed to meet dissolution specifications. The capsules were manufactured by Stason Pharmaceuticals, Inc., and distributed by Amerigen Pharmaceuticals Inc.
The affected lots are 18J043A and 18J043B, both with an expiration date of 09/30/2020. The recall involves 2,413 bottles of the 5-count package and 3,355 bottles of the 14-count package. The product was distributed to four wholesalers/distributors and one retail account, which may have further distributed the product throughout the United States.
This is an FDA Class III recall. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- 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
- Manufacturer
- Amerigen Pharmaceuticals Inc.
- Category
- Drug — Oncology
- Hazard
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 (3)
- Lot #: a) 18J043A
- Exp 09/30/2020
- b) 18J043B
Distribution
Distribution scope not specified by the agency.
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