Glenmark Generics recalls batch of birth control pills

By Dr. Ananya Mandal, MDFeb 27 2012

Drug manufacturer Glenmark Generics, announced last Friday, that it is recalling seven lots of birth control pills because in some packages, the pills were in the wrong order.

The company based in India, did not say how many pills or packages are being recalled. Glenmark said the pills were distributed between Sept. 21 and Dec. 30. The ingredients of the pills are Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg.

Birth control pills need to be taken in a schedule. A month's supply of birth control pills contains three different medications that are each taken one a day for a week, and a week's worth of inert pills. If the pills are taken out of order, they may not work. Glenmark's pills were intended to be taken in this order: seven off-white tablets, seven light blue tablets and seven blue tablets, followed by a week of green placebo pills. When taken properly, birth control pills are nearly 100 percent effective.

In some packages, blisters of pills were rotated so they were not in the proper sequence. The error also made the lot number and expiration date harder to see, and company said the recall applies to any blister package for which the lot number and expiration date are not visible.

Pfizer Inc., the largest drugmaker in the world, announced a similar recall on Feb. 1. The company pulled about 1 million packets of Lo/Ovral-28 and its generic equivalent off the market, although it announced that only about 30 packets had the pills out of order.

These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (lot numbers are provided below) should notify their physician and return the product to the pharmacy.