PRIMIDONE

Generic: PRIMIDONE

Oxford PharmaceuticalsManufacturer
ORALRoute
PRIMIDONEActive Substance
2005-02-24Original Approval

PRIMIDONE is FDA application ANDA040586, sponsored by OXFORD PHARMS. 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 III2026-05-01
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Hea

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Class III2026-04-27
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Inco

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Class III2026-04-27
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, In

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Class III2026-05-01
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American He

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Class III2026-06-03
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin

Class III2026-04-24
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136,

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Top Reported Reactions

1
DRUG INEFFECTIVE
731 reports
2
FATIGUE
576 reports
3
FALL
574 reports
4
TREMOR
507 reports
5
OFF LABEL USE
452 reports
6
DIARRHOEA
432 reports
7
DIZZINESS
419 reports
8
NAUSEA
401 reports
9
DRUG INTERACTION
350 reports
10
SOMNOLENCE
335 reports