Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets

By :

New Ebola Vaccine for Exposure Risk

Weston, Florida, Apotex Corp . is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany. Risk Statement : As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed. To date, no case has been reported for pregnancy and adverse event to Apotex. Patients who have received impacted lots of Drospirenone and Ethinyl Estradiol Tablets, USP 3MG/0.03MG. or have questions regarding this recall please contact your pharmacy. Individuals should not interrupt their therapy, use a non-hormonal method of birth control, contact their health care provider for medical advice and may return the impacted packages to their pharmacist. Drospirenone and Ethinyl Estradiol Tablets, USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablets (inner carton) consists of 28 film-coated, biconvex tablets in the following order: 21 yellow color tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), and 7 placebo white color tablets. The affected Drospirenone and Ethinyl Estradiol Tablets, USP lots include the following and can be identified by NDC numbers stated on the inner and outer cartons: (Source:News Feeds) #FDA #Alert
Rate UsDon’t love itNot greatGoodGreatLove itRate Us
Your opinion
arrow&v
arrow&v

PHAF Team

FDA action against 14 companies for selling illegal cancer treatments

PHAF Team

Patient Receiving Ocrelizumab may be associated with PML

PHAF Team

Drug Alert : 60 drugs found substandard

PHAF Team

Torrent Pharmaceuticals Limited - Recall of Losartan Potassium Tablets

PHAF Team

After Fortis - Now Medanta hospital in Gurgaon charges massive Rs 16 lakh; 7-year-old dies

PHAF Team

FDA Alert - Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and

© 2019 PHAF  || All rights reserved

  • Facebook Social Icon
  • Twitter Social Icon
  • Google+ Social Icon
  • YouTube Social  Icon
  • Instagram Social Icon

Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.