Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures
Amerigen Pharmaceuticals is recalling Temozolomide capsules because stability testing revealed out-of-specification dissolution results.
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 as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation and quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Amerigen Pharmaceuticals Inc. is recalling Temozolomide capsules, 20 mg, in 5-count and 14-count bottles. The recall was initiated because out-of-specification dissolution results were obtained during stability testing.
The affected product was distributed nationwide in the United States. The specific lots involved are 17F058A and 17F058B, both with an expiration date of 6/19. A total of 5,232 bottles are included in this recall.
Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled description, they should contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- 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.
- Manufacturer
- Amerigen Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- 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) 17F058A
- Exp 6/19
- b) 17F058B
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Amerigen Pharmaceuticals Inc.
See all →- LowAmerigen Recalls Temozolomide Capsules Due to Dissolution Failures
FDA (Drugs) · 2019-02-27
- LowAmerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications
FDA (Drugs) · 2019-01-02
- ModerateAmerigen Recalls Temozolomide Capsules Due to Dissolution Failures
FDA (Drugs) · 2019-01-02
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