Recalls

More birth control pills recalled due to packaging error

More birth control pills are being recalled due to packaging error that may leave women without adequate contraception and at risk for unintended pregnancy. The latest batch of pills are made by Glenmark Generics Inc. USA and involve seven lots 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. The recall comes five months after Qualitest Pharmaceuticals announced a massive recall of 1.4 million lots of birth control pills for a similar packaging error.

The recall is being implemented because of a packaging error, where 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. Any blister for which the lot number and expiry date is not visible is subject to recall. The recalled lots can be found on the FDA Recalls website.

This packaging error could interfere with the daily regimen for these oral contraceptives, and could leave women without adequate contraception. To avoid unintended pregnancy, women using the recalled lots of Glenmark Generics birth control pills should begin using a non-hormonal form of contraception immediately. While the pills do not pose any immediate health risks, women who have the recalled pills in their possession should notify their physician and return the pills to the pharmacy where they were purchased. Women should also contact their doctors if they have taken the pills and suspect they are pregnant.

The error was discovered after a customer complained that she had received one blister pack in which the tablets were packaged in reverse order. The correct packaging configuration of this product has three pouch packs packaged in a carton and each pouch pack has one blister which contains 28 tablets (seven tablets each of a different strength and inactive tablets) in which the sequence is white to off-white tablets on the top row and inactive light green tablets in the bottom row.

Any adverse events – such as unintended pregnancies – associated with these recalled pills should be reported to the Food and Drug Administration (FDA) Adverse Event Reporting Program at www.FDA.gov/MedWatch/report.htm.

Sources:
FDA