The Food and Drug Administration has issued recalls for two products: birth control pills packaged by Glenmark Generics and erectile dysfunction pills packaged as herbal remedies by Regenica.

BIRTH CONTROL PILLS

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 expiration date visible only on the outer pouch.

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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.

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:

This packaging related issue was discovered when Glenmark received a complaint from a consumer stating that she received one blister pack in which the tablets were packaged in reverse order. The correct packaging configuration of this product has 3 pouch packs packaged in a carton and each pouch pack has one blister which contains 28 tablets (seven tablets each of a different strength and inactive tablets) in which the sequence is white to off-white tablets on top row and inactive light green tablets in bottom row (correctly packaged blister packs are pictured here):

Each white to off white tablet contains 0.18 mg of the progestational compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP.

Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP.

Each blue tablet contains 0.25 mg of the progestational compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP.

Each light green tablet contains inert ingredients only.

Any adverse events that may be related to the use of these products should be reported to Glenmark Generics Inc., USA at 1-(888)721-7115 (8 AM to 5 PM Mon-Fri EST) or to FDA’s MedWatch Program either online, by regular mail or by fax.

Online:              www.fda.gov/medwatch/report.htm
Regular Mail:   Use postage-paid, pre-addressed Form FDA 3500
available at: www.fda.gov/MedWatch/getforms.htm. Mail
to the address on the pre-addressed form.
Fax:                   1-800-FDA-0178

Glenmark has responded rapidly to ensure that its products continue to meet the company’s high quality standards. The safety of patients who take our medicines is our first priority. The cause was identified and corrected immediately. At this time, there remains sufficient supply of unaffected lots of material in the marketplace to support demand.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

ERECTILE DYSFUNCTION PILLS

Regeneca, Inc. (Pink Sheets:RGNA) announced today that it is conducting a voluntary nationwide recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement. The company, through independent lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.

RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/MedWatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Contact:
Customer Service (800) 690-6958