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Pregnancy Risk Posed by Manufacturing Error Triggers Nationwide Recall
Packaging Problems Could Leave Women Without Adequate Contraception
By News Staff
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.