CLONAZEPAM

Generic: CLONAZEPAM

Par Health USAManufacturer
ORALRoute
CLONAZEPAMActive Substance
2005-08-03Original Approval

CLONAZEPAM is FDA application ANDA077171, sponsored by PH HEALTH. 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 I2024-11-18
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containi

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strip

Class I2024-11-18
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strip

Class I2024-07-10
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 table

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instea

Class I2024-11-18
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strip

Class I2024-11-18
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containin

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strip

Top Reported Reactions

1
DRUG INEFFECTIVE
10,345 reports
2
FATIGUE
7,349 reports
3
NAUSEA
6,670 reports
4
OFF LABEL USE
6,409 reports
5
HEADACHE
6,069 reports
6
PAIN
5,833 reports
7
ANXIETY
5,793 reports
8
DEPRESSION
5,587 reports
9
DYSPNOEA
5,481 reports
10
TOXICITY TO VARIOUS AGENTS
5,176 reports