Norgestimate & Ethinyl Estradiol Tablets
February 27, 2012
Glenmark Generics Inc. has voluntarily recalled 7 lots of norgestimate & ethinyl estradiol tablets. The affected lots are being recalled because of a packaging error. The product is supposed to be packaged in a carton containing a 3 pouch pack. Within each pouch pack is one blister card containing 28 tablets. Some blister packs were rotated 180 degrees during packaging. This could result in the wrong sequence of inactive and active tablets. If the orientation of the medication is reversed, then the expiration date and lot number will only be visible on the outer pouch. The cause of the packaging error has been identified and corrected. The following products are affected:
- Norgestimate and Ethinyl Estradiol 0.18 mg/ 0.035mg, 0.215 mg/ 0.035 mg, 0.25 mg/ 0.035 mg, 3 X 28-count blister packs, NDC 68462-565-29: Lot # 04110101 (expiry 07/31/2013), Lot # 04110106 (expiry 07/31/2013), Lot # 04110107 (expiry 07/31/2013), Lot # 04110114 (expiry 08/31/2013), Lot # 04110124 (expiry 08/31/2013), Lot # 04110129 (expiry 08/31/2013), Lot # 04110134 (expiry 09/30/2013).
Women taking the affected products for contraception may be inadequately protected against pregnancy if the tablet sequence is incorrect. Although this does not pose any immediate health risk, these women may be at risk for unintended pregnancy. Note: Blister packs that are in the wrong sequence will have the expiration date and lot number visible only on the outer pouch. Blister packs that contain the correct sequence will appear normal – that is, each row has different strength color coded tablets as listed: row 1 is off-white to white; row 2 is light blue; row 3 is blue; and row 4 is light green.
Advise patients with the affected products to immediately begin using a nonhormonal contraceptive, contact their physician, and return affected product to the pharmacy. Contact Glenmark Generics at 888-721-7115 with questions about the recall. Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm).
Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
- Photo of unaffected products:
February 27, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.