News Releases

February 28, 2012

Glenmark Generics Inc. Announces a Nationwide Recall of Seven (7) Lots of Norgestimate and Ethinyl Estradiol Tablets

The Missouri Department of Health and Senior Services received the following news release regarding Norgestimate and Ethinyl Estradiol tablets. The recall is being implemented because of a packaging error, where 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.

Lot numbers of affected packs 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 (Generic), are as follows:

NDC

Lot Nos

Expiration

68462-565-29

04110101

07/31/2013

04110106

07/31/2013

04110107

07/31/2013

04110114

08/31/2013

04110124

08/31/2013

04110129

08/31/2013

04110134

09/30/2013

The product is used as an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. 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. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (lot numbers are provided below) should notify their physician and return the product to the pharmacy.

This product was distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011.

The full recall can be found at www.fda.gov/Safety/Recalls/ucm293347.htm?source=govdelivery.

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