A packaging snafu has prompted Pfizer to recall 1 million birth control pill packages. The problem could cause women to take an inadequate dose of their birth control pills, increasing risks for accidental pregnancy.
A total of 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets are involved, said The Associated Press (AP). Both pills are manufactured by Pfizer and marketed in the U.S. by Akrimax Rx Products under the Akrimax Pharmaceuticals brand, the AP added.
Pfizer discovered that some of the drug packets contained too many, and other packets contained two few, of the active tablets. These oral birth control packages should contain 21 active pills and 7 inactive sugar pills that, when taken correctly, regulate menstruation and provide contraception, the AP explained.
A Pfizer spokeswoman said the issue was the result of mechanical and visual inspection failures that occurred on the packaging line. The problem has since been corrected, she said, wrote the AP. A Pfizer-issued statement indicated that the problem was discovered and immediately corrected. Patients in possession of the recalled pills should return them to the pharmacy where purchased.
A complete listing of the recalled products, including lot numbers, can be accessed on the FDA’s website. The recalled packages bear expiration dates that range from July 31, 2013 through March 31, 2014. The recalled birth control pills were distributed to warehouses, clinics, and retail pharmacies throughout the United States, said the AP. The products are packaged in blister packs.
The U.S. Food and Drug Administration (FDA) stressed that the packaging error can impact the daily regimen for these oral contraceptives, rendering the regimen incorrect and leaving women with inadequate contraception protection. Patients in possession of the recalled birth control should utilize another form of birth control and notify their physicians.
Adverse events related to the use of these products should be reported to Akrimax Medical Information, toll-free, at 1.877.509.3935, from 8:00 a.m. to 7:00 p.m., Monday through Friday, Central Standard Time (CST) or to the FDA’s Med Watch Program: 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; or Fax: 1.800.FDA.0178.