Recall: Glenmark Generics Inc. Norgestimate and Ethinyl Estradiol Tablets

Glenmark Generics Inc. Announces a Nationwide 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 (Generic) Due to Possibility of Out of Sequence Tablets
http://www.fda.gov/Safety/Recalls/ucm293347.htm?source=govdelivery

Februray 26, 2012

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a  service to consumers,  the media, and other interested parties. FDA does not endorse either the product or the company.

Glenmark Generics Inc. Announces a Nationwide 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 (Generic) Due to Possibility of Out of
Sequence Tablets

Contact:
Consumer:
1-(888)721-7115

FOR IMMEDIATE RELEASE – February 24, 2012 – Glenmark Generics Inc. USA today 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 packaging error is limited to the seven (7) lots listed in the table below 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. 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 (lot numbers are provided below) should notify their physician and return the product to the pharmacy.

These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and are distributed by Glenmark Generics Inc. USA. This product is distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. This product is distributed by Glenmark Generics Inc. only in the USA.

Get Full Recall List @

http://www.fda.gov/Safety/Recalls/ucm293347.htm?source=govdelivery

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