CLOBAZAM
Generic: CLOBAZAM
Aurobindo Pharma LimitedManufacturer
ORALRoute
CLOBAZAMActive Substance
2022-03-24Original Approval
CLOBAZAM is FDA application ANDA214404, sponsored by AUROBINDO PHARMA LTD. 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 II2025-01-07
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLPresence of Foreign Tablets/Capsules
Class II2024-12-13
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLPresence of Foreign Tablets/Capsules
Class II2019-07-16
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, PrinceMicrobial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumerat
Class II2024-02-12
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured fCGMP Deviations: Out of specification for residual solvents.
Top Reported Reactions
1
SEIZURE
2,914 reports
2
DRUG INEFFECTIVE
2,631 reports
3
OFF LABEL USE
1,855 reports
4
SOMNOLENCE
1,315 reports
5
DRUG INTERACTION
1,032 reports
6
EPILEPSY
792 reports
7
CONDITION AGGRAVATED
741 reports
8
FATIGUE
725 reports
9
STATUS EPILEPTICUS
614 reports
10
MULTIPLE-DRUG RESISTANCE
571 reports