Glenmark Generics Inc. has issued a voluntary nationwide recall of seven lots of the oral contraceptives norgestimate and ethinyle estradiol, after consumers reported that the tablets in some packages were in reverse order.
“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,” the manufacturer said in a press release.
Lot numbers for the affected 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 are as follows:
- 04110101, expiration date 07/31/2013
- 04110106, expiration date 07/31/2013
- 04110107, expiration date 07/31/2013
- 04110114, expiration date 08/31/2013
- 04110124, expiration date 08/31/2013
- 04110129, expiration date 08/31/2013
- 04110134, expiration date 09/30/2013
Women in possession of these lots should begin using non-hormonal forms of contraception immediately, and notify their health-care provider. Affected products should be returned to the pharmacy.
Correctly packaged products (pictured) consist of a blister card with 28 tablets in four rows, with white to off-white tablets in the top row (0.18 mg norgestimate/0.035 mg ethinyl estradiol), light blue tablets in the second row (0.215 mg norgestimate/0.035 mg ethinyl estradiol), blue tablets in the third row (0.25 mg norgestimate/0.035 mg ethinyl estradiol) and light green placebo pills in the fourth row.
Products with the packaging errors were distributed to wholesalers and retail pharmacies across the United States between Sept. 21, 2011 and Dec. 30, 2011.
This is the second time this month a drug manufacturer has recalled oral contraceptives for packaging problems. In early February, Pfizer pulled 28 lots of Lo/Ovral-28 and generic formulations of norgestrel and ethinyl estradiol tablets.