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 Pharmaceutical

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification

Class I2020-02-07
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries L

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not

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 42192-614-30

Labeling: 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 Bridgewater

Failed 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
3,264 reports
2
DRUG INTERACTION
1,789 reports
3
SEIZURE
1,745 reports
4
TOXICITY TO VARIOUS AGENTS
1,565 reports
5
CONVULSION
1,303 reports
6
OFF LABEL USE
1,243 reports
7
STATUS EPILEPTICUS
892 reports
8
PYREXIA
788 reports
9
FALL
724 reports
10
DIZZINESS
705 reports