NEW YORK, Feb. 1 (UPI) -- Pfizer Inc. voluntarily recalled 14 lots of Lo/Ovral-28 and 14 lots of generic Norgestrel and Ethinyl Estradiol due to a packaging error, U.S. officials said.
A statement by Pfizer said: "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 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."
The daily dose of the oral contraceptives may be incorrect -- each package contains 21 tablets of active ingredients and seven tablets of inert ingredients -- and could leave women without adequate contraception putting them at risk for unintended pregnancy, Pfizer said. Correct dosing is key to preventing an unplanned pregnancy.
Although the packaging defects do not pose any immediate health risks, consumers exposed to the affected packaging should begin using a non-hormonal form of contraception immediately.
Women who have taken the affected product should notify their physician and return the product to the pharmacy, the FDA said.
Any adverse events should be reported to Akrimax Medical Information at 1-877-509-3935 (8 a.m. to 7 p.m. Mon-Fri CST) or to the FDA's Med Watch Program at www.fda.gov/medwatch/report.htm or fax number 1-800-FDA-0178.