ESTRADIOL / NORETHINDRONE ACETATE
Generic: ESTRADIOL AND NORETHINDRONE ACETATE
Breckenridge PharmaceuticalManufacturer
ORALRoute
ESTRADIOLActive Substance
2008-04-17Original Approval
ESTRADIOL / NORETHINDRONE ACETATE is FDA application ANDA078324, sponsored by BRECKENRIDGE PHARM. 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 III2017-01-30
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7Chemical Contamination: out of specification results for impurities were found to be the result of c
Class II2021-07-30
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Failed Stability Specifications; out of specification for shear.
Class II2021-07-30
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 SyFailed Stability Specifications; out of specification for shear.
Top Reported Reactions
1
NAUSEA
430 reports
2
HEADACHE
421 reports
3
HOT FLUSH
391 reports
4
FATIGUE
340 reports
5
DRUG INEFFECTIVE
308 reports
6
OFF LABEL USE
292 reports
7
PAIN
285 reports
8
ABDOMINAL PAIN
272 reports
9
VAGINAL HAEMORRHAGE
271 reports
10
ARTHRALGIA
234 reports