FDA Issues Warning about Defective Product – Birth Control Blister Packs

In May 2017, the U.S.  Food and Drug Administration (FDA) issued a warning about a defective product – birth control blister packs. The defect is risky due to compromising the effectiveness of birth control drug Mibelas.  Distributed across the nation to pharmacies, retailers, and wholesalers, the FDA is warning doctors, pharmacists, and consumers to beware of the defective product.  The manufacturer, Lupin Pharmaceuticals, Inc.  has issued a recall.

Millions of women take birth control pills everyday to prevent pregnancy, manage hormone-related medical conditions, or control menstruation.  When medications are defective, it puts women at risk for adverse events ranging from ineffectiveness to serious injury or illness.  In the case of the Mibelas recall, the defective blister packs pose the risk for unintended pregnancy as well.  Read on to learn more about the recall and FDA safety alert.

Information About Mibelas

According to the FDA report, Lupin Pharmaceuticals, Inc.  issued a recall of Mibelas birth control blister packs after a market complaint indicated an error in the packaging.  Investigation revealed that blister packs in specific lots of the drug were rotated 180 degrees inside the wallet.  This rotation resulted in the weekly orientation of the drug being incorrect, with the first four days of birth control being placebo rather than the active tablets.

The packaging error caused consumers relying on the standard orientation to take the product out of sequence, which can result in unintended pregnancy or other side effects depending on why the drug is being used.  Women in whom pregnancy is contraindicated are particular targets of the warning as pregnancy could have adverse fetal or maternal consequences, including death.

Recalled Mibelas Products

The products affected by the recall include lot L600518 of Mibelas 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol 1mg/0.02 mg chewable and ferrous fumarate 74 mg).  The blister packs contain 28 tablets identified as:

  • 24 white or off-white tablets debossed with “N81” on one side and “LU” on the other
  • 4 tan tablets debossed with “M22” on one side and “LU” on the other

The Mibelas defective product included in the recall have an expiration date of 5/18, though it was noted in the FDA safety alert that the disoriented packaging may shield the expiration date altogether.

Consumers who have a defective product included in the recall are instructed to return the product to the pharmacy and contact their healthcare provider immediately.  They are also encouraged to file a report with the FDA’s MedWatch Adverse Event Reporting Program if they experience any side effects.

Consumers using Mibelas products are urged to contact their healthcare provider immediately if they experience adverse side effects from using the product.  It is also advisable to contact a medical malpractice or birth injury attorney to discuss your legal rights.  Injuries caused by defective products are never acceptable, and you deserve the chance to defend your rights.

What to Know about Defective Medical Products

Defective medical products, including medications, fall under the umbrella of medical malpractice.  In the case of defective birth control, adverse side effects may also fall under the category of birth injuries if you become pregnant or are pregnant.

As a patient, you rely on the expertise and training of doctors, pharmacists, and manufacturers to only do what’s best for you.  Manufacturers are tasked with complying with federal guidelines in ensuring their products are safe and effective as marketed.  When products fail to conform, manufacturers are required to communicate risks to healthcare providers and issue a recall of the defective product if necessary.

Doctors are required to stay informed about medications and medical devices they use, including staying abreast of FDA warnings or recalls.  They also must inform patients about the risks of certain medications or medical devices, and offer guidance accordingly.  Pharmacists have similar responsibilities with medications and must be careful to properly interpret prescriptions, offer guidance to patients, and recognize risks or problems.

Defective Medications and Your Rights

As for your rights – as a patient, you have the right to quality care that is in accordance with acceptable medical standards and ethics.  When manufacturers or healthcare providers deviate from their duty of care to you and you are injured as a result, your legal rights likely have been violated.  In such cases, it is important that you contact a medical malpractice or birth injury attorney to discuss your case.

Medical malpractice and birth injury cases are often complicated.  There are a variety of laws and legal guidelines that must be followed, and there are timelines for doing so called the statute of limitations.  That’s why it is so important to get the help of a medical malpractice or birth injury attorney as soon as possible.

At Brown & Brothers, we have experience litigating a variety of medical malpractice and birth injury cases, including cases involving defective medical devices or medications.  Our focus is providing high quality, compassionate legal representation that your family can trust.  Contact our office today to start defending your rights.  Fill out our online form to schedule a free case review.

 

Sources:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560908.htm

http://www.al.com/news/index.ssf/2017/06/packaging_error_means_birth_co.html

https://www.fda.gov/Safety/Recalls/ucm560904.htm