Reported Oct 24, 2018 · Terminated
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14),…
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, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd
- byStason Pharmaceuticals, Inc., Irvine, CA 92618, Dist
- ByAmerigen Pharmaceuticals, Lyndhurst, NJ 07071
- Lot codes and dates
Lot #: a) 17F058AExp 6/19b) 17F058BExp 6/19
- Amount recalled
- 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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