FDA-Drug2019-02-27Class III
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
Amerigen Pharmaceuticals Inc.
Hazard
Failed dissolution specifications
Sold states
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
Affected count
a) 2,413 bottles b) 3,355 bottles
Manufactured in
9 Polito Ave Ste 900, Lyndhurst, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2019Don't want to check this manually?
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