- Contact Us
- News and Events
- Investor Relations
- Locations and Facilities
- Careers
- About Our Site
- Accessibility Statement
- Privacy Policy
- Terms and Conditions
- For Employers and Medical Plan Providers
- For Pharmacists and Medical Professionals
- Drug Lists
- Drug Safety Alerts
- Emergency Response
- Mail Service Numbers, Forms and Information
- Specialty Pharmacy Services, Information and Forms
- Electronic Prior Authorization Information
- Clinical Drug Information
- Clinical Programs and Health Management
- Clinical Publications
- FAQs For Pharmacists and Pharmacy Staff
- Pharmacy Help Desk
- FAQs For Prescribers and Office Staff
- Contact Us | Health Professionals Only
Drug Safety Alerts
Mibelas™ 24 Fe tablets Consumer-Level Recall
5/26/2017
On May 26, 2017, Lupin Pharmaceuticals, Inc. issued a consumer‑level recall of MibelasTM 24 Fe (norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets). It is available in cartons (NDC 68180-0911-13) containing three pouches, each pouch containing a wallet of 28 tablets (NDC 68180-0911-11). This recall was issued due to a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets. As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.
This recall affects lot number L600518 exp. 05/31/18. The recalled lot went in distribution on March 15, 2017.
This recall was originally issued to the retail-level on May 17, 2017. The manufacturer expanded the recall to consumer-level on May 26, 2017.
CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using MibelasTM 24 Fe tablets to contact their prescriber.
For more information about this recall, health care providers may contact Lupin Pharmaceuticals, Inc at 1-866-587-4617. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.