Norgestrel Birth Control Pills Recalled Due to Packaging Error
About 1 million Lo/Orval-28 and generic norgestrel birth control pills are being recalled by Pfizer due to a packaging error, which may cause unintended pregnancy.
Pfizer announced the birth control pill recall on January 31, indicating that some blister packs could contain the wrong number of pills and that the tablets may be out of sequence.
Women following the package directions may not be effectively protected against pregnancy, the company warns. This may not only result in unwanted pregnancies, but could also pose a serious risks for some pregnancies where the mother may be taking other medications that carry a risk of birth defects or malformations.
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The recalled birth control pills include 14 lots of Lo/Ovral-28 and 14 lots of generic equivalents. Both are norgestrel and ethinyl estradiol tablets sold to consumers in the United States. The pills were manufactured by Pfizer and distributed under the Akrimax Rx Products label. A full list of affected lot numbers, NDC codes and expiration dates is located in the Pfizer recall announcement.
In September, a similar recall was announced for birth control pills distributed by Qualitest Pharmaceitucals. In that incident, the blister packages were rotated 180 degrees during packaging, reversing the weekly tablet orientation.
According to Pfizer officials, some of the packages in the latest recall had too many active ingredient tablets, while some had too few. The packages are supposed to include 21 active ingredient birth control pills and seven sugar pills in order to regulate the menstrual period.
Pfizer officials indicate there is no safety risk with the pills beyond the increased chance of a pregnancy.
Consumers with questions or who suffer adverse events are asked to call Akrimax Medical Information at (877) 509-3935. Those suffering adverse events should also contact the FDA MedWatch Adverse Event Reporting Program.
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