Reported Jan 2, 2019 · Terminated
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine,…
Amerigen Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amerigen Pharmaceuticals Inc. · 9 Polito Ave Ste 900 · Lyndhurst, NJ · 07071-3410
Is this the product you have?
- Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd
- byStason Pharmaceuticals, Inc., Irvine, CA, Dist
- ByAmerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
- Lot codes and dates
Lot # 18E031exp 05/2020
- Amount recalled
- 771 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Failed Dissolution Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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