Prescription Report

Lo/Ovral Recall Information from Pfizer

admin — Wed, 01 Feb 2012 20:10:05 +0000

Women using Lo/Ovral birth control should be advised that there has been a voluntary recall of the pills by Pfizer, the maker of Lo / Ovral. It appears the dosages may not be correct in some of the pills making pregnancy more likely than with correct dosage.

——— Press Release —————–

February 01, 2012 01:35 PM EST

Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral^®-28 And Norgestrel/Ethinyl Estradiol Tablets Due To Possibility Of Inexact Tablet Counts Or Out Of Sequence Tablets

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral^®-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. The cause was identified and corrected immediately.

These products are oral contraceptives indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. These tablets were manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. This product is distributed to warehouses, clinics and retail pharmacies nationwide.

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 products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy.

Correctly Packaged LoOrval Blister Pack Image - www.pfizer.com/img/news/LoOvralCorrectPkg.jpg

Correctly Packaged Norgestrel Image - http://www.pfizer.com/img/news/NorgestrelCorrectPkg.jpg

Any adverse events that may be related to the use of these products should be reported to Akrimax Medical Information at 1-877-509-3935 (8 AM to 7 PM Mon-Fri CST) or to FDA’s Med Watch Program either online, by regular mail or by fax.

Online:			www.fda.gov/medwatch/report.htm1
Regular Mail:			Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to the address on the pre-addressed form.
Fax:			1-800-FDA-0178

Pfizer 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.

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

Lot numbers of affected packs of Lo/Ovral^®-28 (norgestrel and ethinyl estradiol) Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:

NDC

Product

Lot

Expiration

Configuration/Count

24090-801-84

LO/OVRAL^® 28

E15678

08/31/2013