Pfizer Issues Statement On Voluntary Recall

To View a Video Statement from Pfizer Executive Vice President and Chief Medical Officer Dr. Freda Lewis-Hall please visit: https://rcpt.yousendit.com/1361067074/75162320027a1c128e5de39016f4bc66

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. today issued the following statement regarding the voluntary recall of Lo/Ovral®-28 (norgestrel and ethinyl estradiol):

“We have announced a voluntary recall of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States.

“We understand that this news can be very concerning and confusing for any woman who takes birth control pills to protect against unintended pregnancies.

“We share your concerns and want to provide you with the most up-to-date and accurate information.

“Recently, it came to our attention that there may be an issue with the way some of these pills were packaged…and that the inactive or placebo pill may have been placed out-of-order in some packs.

“Upon discovery of the issue, we took corrective action and notified the FDA.

“Based on our own rigorous internal assessments of this problem, we believe there are approximately 30 packs of birth control pills that may have received an inexact count or inactive tablet.

“Because of our high quality standards, should we identify even one package that does not meet our high standards, we will voluntarily recall the entire lot.

“Therefore, we have voluntarily recalled the 28 lots - which is approximately 1 million packs - to ensure that any possibly impacted product is removed from pharmacy shelves - and women who use the product are alerted.

“If you are a woman in the United States who has used Lo-Ovral or Norgestrel pills over the last several months, please consult with your physician and begin using a non-hormonal barrier method immediately.

“Patients can view pictures of the affected products and lot numbers included in the recall by visiting:

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

To view lot numbers:
http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp#guid=20120131007121en&source=RSS_2011&page=1

To view video:
http://youtu.be/zcLIbeVHGgY

“Patients are our first priority, and at Pfizer we are committed to providing quality medicines.”

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50154194&lang=en



CONTACT:

Pfizer Inc.
Grace Ann Arnold, 845-602-4768

KEYWORDS:   United States  North America  New York

INDUSTRY KEYWORDS:   Women  Health  Pharmaceutical  Communications  Public Relations/Investor Relations  FDA  Consumer  General Health

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