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Alert is issued for mislabeled OCs
Another oral contraceptive (OC) packaging alert has been issued. Check your clinic's stock for norgestimate and ethinyl estradiol birth control pills distributed by Glenmark Generics.
The Mahweh, NJ-based company recently issued a voluntary, nationwide, consumer-level recall of seven lots of the Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg) pills because a packaging error could leave women without adequate contraception and at risk for unintended pregnancy.
The packaging defects do not pose any immediate health risks, the company states; however, consumers exposed to affected packaging should begin immediate use of a nonhormonal form of contraception. Patients with affected product should be instructed by clinicians to return the product to the pharmacy.
The tablets were manufactured and packaged by Glenmark Generics of Mumbai, India, and are distributed by the company's U.S. division. The product was distributed to wholesalers and retail pharmacies nationwide between Sept. 21, 2011 and Dec. 30, 2011.
Look for lot numbers
The packaging error occurred when select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. Any blister for which the lot number and expiry date is not visible is subject to recall. The packaging error is limited to the following seven lots listed of Norgestimate and Ethinyl
Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (listed by lot number, expiration date): 04110101, 07/31/2013; 04110106, 07/31/2013; 04110107, 07/31/2013; 04110114, 08/31/2013; 04110124, 08/31/2013; 04110129, 08/31/2013; and 04110134, 09/30/2013.
According to the company, the packaging related issue was discovered when a consumer complaint was received regarding a blister pack with pills packaged in reverse order. The correct packaging configuration calls for three pouch packs packaged in a carton, with each pouch pack having one blister containing 28 tablets (seven tablets each of a different strength and inactive tablets) in which the sequence is white to off-white tablets on the top row and inactive light green tablets in the bottom row.
Any adverse events that might be related to the use of the recalled product should be reported to Glenmark Generics at (888) 721-7115 from 8 a.m. to 5 p.m. Monday to Friday. Adverse events also may be reported to the Food and Drug Administration's (FDA) MedWatch Program. Go to www.fda.gov/Safety/MedWatch/default.htm, and click on "Report A Serious Medical Product Problem Online" to access Form FDA 3500. Events may be entered online; the form may be printed and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; or it may be faxed to (800) 332-0178.
Are OCs in your stock?
The recall marks the third OC packaging recall since October 2011. However, there is a reasonably high likelihood that the Glenmark recall has not made an impact in your practice, as the company recently entered the U.S. generic contraceptive market.
The company received its first FDA approval in April 2010 for Heather, the generic equivalent of Nor-QD (Watson Pharmaceuticals), followed by the July 2010 approval of norethindrone 0.35 mg, the generic version of Micronor (Janssen Pharmaceuticals). Since then, it has received approval for Briellyn, the generic version of Ovcon 35 (Warner Chilcott); Alyacen 1/35, the generic version of Ortho-Novum 1/35 (Janssen Pharmaceuticals); Alyacen 7/7/7, the generic version of Ortho-Novum 7/7/7 (Janssen Pharmaceuticals); and Marlissa, the generic version of Nordette (Duramed Pharmaceuticals). The FDA approval for the norgestimate and ethinyl estradiol tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg) pills, the generic version of Ortho Tri-Cyclen, came in June 2011.