Amerigen Pharmaceuticals Inc. recalls Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), R…
- Recall date
- October 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0249-2019
- FDA classification
- Class III
- Brand / firm
- Amerigen Pharmaceuticals Inc.
- Sold / distributed
- Product was distributed U.S. nationwide.
Why it was recalled
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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