Pfizer Inc. says it has voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market.
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. (Birth control packs include pills without active ingredients that allow a woman to have a monthly menstrual cycle.)
As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect (the inactive pills may be taken on the wrong days) and could leave the user at risk for unintended pregnancy.
Pfizer notes the recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients.
The cause was identified and corrected immediately, according to the company’s press release.
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.
Consumers who may have used pills from the affected packaging (click here for a list of the Lot numbers http://www.fda.gov/Safety/Recalls/ucm289770.htm ) should begin using a non-hormonal form of contraception immediately, notify their physician and return the product to the pharmacy.
Any adverse events that may be related to the use of these products should be reported to Akrimax Medical Information at 1-877-509-3935 (8 AM to 7 PM Mon-Fri CST) or to FDA’s Med Watch Program either online, by regular mail or by fax.
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.
Posted Feb. 3, 2012
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