On January 31, 2012, Pfizer announced a voluntary nationwide recall of a million packs of oral contraceptives. The recall affects both the brand-name Lo/Ovral-28, and the generic Norgestrel and Ethinyl Estradiol Tablets. Both of these drugs are marketed and labeled by Akrimax Rx Products, carrying the label of that company on the packaging.
According to the FDA press release announcing the recall, Pfizer took action after their own investigation revealed that some packages of the oral contraceptive may contain the incorrect amount of active-ingredient tablets and that the tablets in the packages may be out of sequence. The problem has since been remedied, but not before 28 lots of the drug were packaged and put on the shelves. The FDA announcement includes a list of all lot numbers that were affected. That same press release also has photographs to help patients identify if their product is included in the recall.
Typically these birth control pills contain 21 white pills with an active ingredient and then seven pink pills that are inert. The effectiveness of the contraceptives depends on the pills being taken in a specific sequence. Simply taking the pills in the wrong order—which is much more likely in the recalled packages—can eliminate the contraceptive effect of the pills and increase the likelihood of pregnancy. While there are no other health risks, the FDA advises users of the product to begin using a non-hormonal contraception immediately. In addition, patients prescribed these birth control pills should immediately notify their physician and return the product to the pharmacy.
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"According to the FDA press release announcing the recall, Pfizer took action after their own investigation revealed that some packages of the oral contraceptive may contain the incorrect amount of active-ingredient tablets and that the tablets in the packages may be out of sequence." A Drug Master File is a submission to the U.S. FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. For more information visit LINK
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