NORGESTIMATE AND ETHINYL ESTRADIOL

Generic: NORGESTIMATE AND ETHINYL ESTRADIOL

Naari Pte LimitedManufacturer
2015-04-07Original Approval

NORGESTIMATE AND ETHINYL ESTRADIOL is FDA application ANDA200384, sponsored by NAARI PTE. 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 II2025-09-02
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x2

Failed Content Uniformity Specifications

Top Reported Reactions

1
PREGNANCY ON ORAL CONTRACEPTIVE
56 reports
2
DRUG INEFFECTIVE
45 reports
3
NAUSEA
38 reports
4
MATERNAL EXPOSURE DURING PREGNANCY
37 reports
5
DRUG DOSE OMISSION
36 reports
6
NO ADVERSE EVENT
31 reports
7
DRUG INTERACTION
29 reports
8
PRODUCT QUALITY ISSUE
29 reports
9
VOMITING
29 reports
10
HEADACHE
28 reports