Reported Feb 27, 2019 · Terminated
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx…
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, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd
- byStason Pharmaceuticals, Inc., Irvine, CA 92618, Dist
- ByAmerigen Pharmaceuticals, Lyndhurst, NJ 07071
- Lot codes and dates
Lot #: a) 18J043AExp 09/30/2020b) 18J043BExp 09/30/2020
- Amount recalled
- a) 2,413 bottles b) 3,355 bottles
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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