GLIMEPIRIDE
Generic: GLIMEPIRIDE
Florida Pharmaceutical ProductsManufacturer
ORALRoute
GLIMEPIRIDEActive Substance
2013-04-17Original Approval
GLIMEPIRIDE is FDA application ANDA202112, sponsored by REGCON HOLDINGS. 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 III2024-01-18
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 Misprint on tablet
Class II2023-02-07
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-cCGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-03-16
Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-CGMP Deviations
Class III2024-01-18
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 Misprint on tablet
Class II2023-02-07
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 TabletsCGMP Deviations: recalling drug products following an FDA inspection.
Class II2014-10-09
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only,Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification result
Class II2023-02-07
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-coCGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-03-16
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120CGMP Deviations
Top Reported Reactions
1
BLOOD GLUCOSE INCREASED
3,009 reports
2
NAUSEA
2,339 reports
3
DIARRHOEA
2,262 reports
4
DRUG INEFFECTIVE
1,945 reports
5
FATIGUE
1,877 reports
6
HYPOGLYCAEMIA
1,679 reports
7
WEIGHT DECREASED
1,416 reports
8
DIZZINESS
1,396 reports
9
VOMITING
1,354 reports
10
DYSPNOEA
1,348 reports