FDAFDA · Food and drugs·Recall number D-0516-2019
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
Published February 27, 2019 · Recall initiated: February 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerigen Pharmaceuticals Inc.
- Distributor
- Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
- Lot
- Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.