FDA-Drug2019-01-02Class III
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
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
3552 bottles
Manufactured in
9 Polito Ave Ste 900, Lyndhurst, NJ, United States
Products
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0344-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief