FDA-Drug2013-11-13Class II
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Amneal Pharmaceuticals of New York, LLC.
Hazard
Failed dissolution specifications; 18 month CRT
Sold states
IL, NH, NJ, NY, OH, RI, TN
Affected count
895 - 1000 count bottles
Manufactured in
85 Adams Avenue, N/A, Hauppauge, NY, United States
Products
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66014-001Don't want to check this manually?
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