FDA-Drug2019-01-02Class III
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
Amerigen Pharmaceuticals Inc.
Hazard
Failed Dissolution Specifications
Sold states
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
Affected count
771 bottles
Manufactured in
9 Polito Ave Ste 900, Lyndhurst, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0345-2019Don't want to check this manually?
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