Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine,…
- Recall date
- December 20, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0345-2019
- FDA classification
- Class III
- Brand / firm
- Amerigen Pharmaceuticals Inc.
- Sold / distributed
- Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
Why it was recalled
Failed Dissolution Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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