Nationwide Recall of Oral Contraceptive Because of a Packaging Error

Hands hold a package of birth control pills, pressing their thumb into a blister on the first row of the package.

Defective Birth Control Pill Recalled

When consumers pick up prescription medications from their local pharmacies, they should be able to trust that the drug they are taking is safe for use, and that it was properly manufactured and packaged without defects. However, there are many different kinds of product defects that can occur from the process of designing to marketing medications, and in some cases, safety defects can result in recalls of dangerous drugs. According to a recent article in Endocrinology Advisor, an oral contraceptive has been recalled as a result of a packaging error. While the drug might not place patients at risk of serious injury, it is nonetheless important to understand the risks associated with this type of recall and for patients to follow the recall instructions.

The recalled product includes four lots of Drospirenone and Ethinyl Estradiol Tablets (3 mg/0.03 mg). According to the article, the recall is “due to the possibility of defective blisters with incorrect tablet arrangements and/or empty blister pockets.” This particular oral contraceptive is a combination oral contraceptive that includes both estrogen and progestin. Its primary use is for pregnancy prevention. Accordingly, the primary risk associated with using the defective birth control pill is “loss of efficacy.” In other words, patients could become pregnant if they “do not take the appropriate tablet or miss a tablet.” The drug company Apotex reports that is has not yet received any reports from consumers about adverse events associated with use of the improperly packaged product.

The lots that are subject to the Drospirenone and Ethinyl Estradiol recall include the following: 7DY008A, 7DY009A, 7DY010A, and 7DY011A. To determine whether you have the product involved in the birth control recall, you should check the outer carton, which has this identifying information: NDC# 60505-4183-3. The expiration date on the defective birth control pill is 8/2020. All lots were manufactured by Oman Pharmaceutical Products Co., LLC, and they were distributed to patients across the U.S.

Learning More About Dangerous Drugs and Recalls

The U.S. Food and Drug Administration (FDA) has a recall classification system that works like this:

  • Class I: this is the most dangerous type of drug recall, and it means that using the product “could cause serious health problems or death”;
  • Class II: this is the second-most serious type of drug recall, and it means that the product “might cause a temporary health problem, or pose slight threat of a serious nature”; and
  • Class III: this recall classification is the least serious, and it means that the product “is unlikely to cause any adverse health reaction, but that [it] violates FDA labeling or manufacturing laws.”

An article in WebMD cites all of the following as potential reasons for recalling a medicine or drug:

  • Medicine poses a health hazard;
  • Drug has been mislabeled;
  • Drug is poorly packaged;
  • Product is potentially contaminated;
  • Wrong drug inside the box, or wrong label;
  • Medicine has been poorly manufactured.

Were you injured after using a defective birth control pill or other dangerous drug? You should discuss your options with a product liability lawyer.

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