ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL

Generic: ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL

Mylan Pharmaceuticals Inc.Manufacturer

2016-02-09Original Approval

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL is FDA application ANDA204704, sponsored by XIROMED. 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 0378-7

Chemical Contamination: out of specification results for impurities were found to be the result of c

Class II2018-12-26

Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-71

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Class II2021-04-16

Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami,

Defective Delivery System: Out of specification for release rate testing and shear, an attribute rel

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

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 II2019-10-22

Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Class II2022-01-26

ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-089

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Class II2018-03-19

Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC

Defective Container: This recall is being initiated due to product complaints regarding difficulty i

Class III2024-05-16

Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmed

Failed Impurities/Degradation Specifications.

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 Sy

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL

Recalls

Top Reported Reactions