PHENYTOIN SODIUM
Generic: PHENYTOIN SODIUM
Acella PharmaceuticalsManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
PHENYTOIN SODIUMActive Substance
2006-09-13Original Approval
PHENYTOIN SODIUM is FDA application ANDA040573, sponsored by ACELLA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2023-05-30
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal PharmaceuticalFailed Dissolution Specifications: Out-of-specification results for dissolution (above specification
Class III2022-11-14
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30Labeling: Not elsewhere classified; the product is being recalled because of customer complaints tha
Class II2023-10-27
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC BridgewaterFailed Dissolution Specifications
Class III2022-11-14
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10,Labeling: Not elsewhere classified; the product is being recalled because of customer complaints tha
Class II2013-08-17
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 Failed dissolution specifications; 18 month CRT
Top Reported Reactions
1
DRUG INEFFECTIVE
614 reports
2
SEIZURE
352 reports
3
CONVULSION
273 reports
4
DRUG INTERACTION
259 reports
5
TOXICITY TO VARIOUS AGENTS
237 reports
6
DIZZINESS
139 reports
7
FALL
135 reports
8
OFF LABEL USE
126 reports
9
EPILEPSY
124 reports
10
PYREXIA
120 reports