FDA-Drug2018-10-24Class III
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.
Amerigen Pharmaceuticals Inc.
Hazard
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Sold states
Product was distributed U.S. nationwide.
Affected count
5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
Manufactured in
9 Polito Ave Ste 900, N/A, Lyndhurst, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2019Don't want to check this manually?
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