FDAFDA · Food and drugs·Recall number D-0249-2019
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.
Published October 24, 2018 · Recall initiated: October 5, 2018
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: Out-of-Specification dissolution results obtained during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerigen Pharmaceuticals Inc.
- Distributor
- Product was distributed U.S. nationwide.
- Lot
- Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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