Pregnancy Risk Posed by Manufacturing Error Triggers Nationwide Recall

Mahwah, N.J.-based Glenmark Generics Inc. USA announced Feb. 24 that the company would voluntarily recall seven lots of its norgestimate and ethinyl estradiol 0.18 mg/0.035-mg, 0.215 mg/0.035-mg and 0.25 mg/0.035-mg tablets because of a packaging error that could leave women at risk for unintended pregnancy.

Specifically, select blisters in the affected products were rotated 180 degrees within the card, reversing the weekly tablet orientation and rendering the pills out of sequence. In addition, the packaging error makes the lot number and expiration date visible only on the outer pouch. Any blister for which the lot number and expiry date are not visible is subject to recall.

The recalled products were produced at the company's manufacturing plant in Goa, India, which serves as Glenmark's main manufacturing facility for products bound for the U.S. market. The plant was first inspected and approved by the FDA in June 2005.

Although the defects do not pose any immediate health risk, according to the manufacturer, women who have been exposed to recalled product should begin using a nonhormonal form of contraception immediately. Patients who have affected product are advised to notify their physician and return the product to the pharmacy.

The affected lot numbers and expiration dates, as well as a detailed description of the products' correct packaging orientation, are available online.

The FDA is asking health care professionals and patients to report any adverse events related to the use of these products to its MedWatch Safety Information and Adverse Event Reporting Program. Adverse events also may be reported to Glenmark Generics Inc. USA toll-free at (888) 721-7115 from 8:00 a.m.-5:00 p.m. EST Monday through Friday.