Glenmark Generics Inc. USA issued a voluntary, nationwide, consumer-level recall of seven (7) lots 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. 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. Any blister for which the lot number and expiry date is not visible is subject to recall.
This 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 should notify their physician and return the product to their pharmacy.
These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and distributed by Glenmark Generics Inc. USA. This product was distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. For lot numbers of affected packs of Norgestimate and Ethinyl Estradiol Tablets, see the FDA announcement (link below).
See the FDA Recall
Note: This recall is separate and distinct from the recall recently announced by Pfizer of its Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol tablets due to the possibility of inexact tablet counts or out of sequence tablets, as noted in the February 13 Scalpel Weekly News.
See the Pfizer FDA Recall