Glenmark Generics is issuing a nationwide recall of seven lots of birth control pills. The pills are labeled “norgestimate and ethinyl estradiol tablets.”
Because of a packaging error, some of the pills were placed in the wrong order within the packs, according to a statement from the Food and Drug Administration. The packs contain three types of pills with varying levels of hormones, designed to be taken at different times during a woman’s cycle.
The pills were rotated 180 degrees within the pack, so the weekly tablet orientation is reversed, and the lot number and expiration date are visible only on the outer pouch, according to the FDA. Any pack for which the lot number and expiry date is not visible is subject to recall.
Because of this error, the daily regimen for these oral contraceptives may be incorrect, leaving women without adequate contraception, and at risk for unintended pregnancy.
These packaging defects do not pose any immediate health risks, but consumers whose pills are affected should begin using a non-hormonal form of contraception immediately, the FDA said. Patients who have the products (lot numbers are provided below) should notify their physician and return the product to the pharmacy.
Lot numbers of affected packs are as follows: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. The packs were distributed nationwide between Sept. 21 and Dec. 30, 2011. The complete name of the product is 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).
The error was discovered when a consumer complained she received a pack in which the tablets were packaged in reverse order, the FDA said.
In the correct packaging configuration, the top row contains seven white to off-white tablets, and the bottom row contains seven inactive, light green tablets in bottom row ( correctly packaged packs are pictured here ).
Last month, Pfizer recalled 28 lots of generic birth control pills labeled Norgestrel and Ethinyl Estradiol tablets, when the company found some packs contained an inexact count of inert or active ingredient tablets, and tablets out of sequence.
More information is available on the FDA’s website.