Pharmaceutical company Glenmark Generics issued a recall on Friday for birth control pills norgestimate and ethinyl estradiol tablets due to a packaging error that poses a risk for consumers to become pregnant, just months after a major recall from another drug company.
According to the recall by the India-based drug company, the oral contraceptive pills, arranged by week in four different colors to distinguish between active and inactive pills, were out of order, which can cause them to be ineffective.
As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy, a Glenmark spokesman said in a statement. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch.
Lot numbers affected are: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. The birth control pills were distributed between the months of September and December in 2011 and have expiration dates between July and September 2013.
According to The Daily Mail, the mistake was discovered by a woman prescribed the pills when she noticed her pack of pills were out of order.
The recall comes one month after Pfizer recalled over one million pills of Lo/Ovral-28 because they couldn't prevent pregnancy.
Glenmark said that those affected should return the recalled pills to their pharmacy and switch to a non-hormonal method of contraception immediately. The affected pill packets do not pose any health risks, Glenmark said, and the company has notified the U.S. Food and Drug Administration.
The safety of patients who take our medicines is our first priority. The cause was identified and corrected immediately, the company said in a statement. At this time, there remains sufficient supply of unaffected lots of material in the marketplace to support demand.
Pharmaceutical company Glenmark Generics issued a recall on Friday for birth control pills norgestimate and ethinyl estradiol tablets due to a packaging error that poses a risk for consumers to become pregnant, just months after a major recall from another drug company. Pictured is the proper order of the pills.
Here is a chart of the Glenmark Genericals birth control pill recall, courtesy of the FDA.
Lot numbers of affected packs of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic), are as follows: