Oral Contraceptives' Packaging Error Prompts Pfizer Recall

Incorrect Daily Regimen Could Pose Pregnancy Risk

February 08, 2012 03:40 pm News Staff

A packaging error has prompted New York-based Pfizer Inc. to recall multiple lots of oral contraceptives(www.fda.gov) after an investigation by the company indicated the error could leave women "without adequate contraception and at risk for unintended pregnancy."

[Lo/Ovral-28 Birth Control Carton and Blister Pack]

In a Jan. 31 press release(www.fda.gov), Pfizer, which manufactures the products, said that it recalled 28 lots of tablets because some of the blister packs may contain an inexact count of inert and active ingredient tablets. In addition, said Pfizer, the tablets might be out of sequence.

The contraceptives are marketed by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand.

The products covered in the recall are 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of generic norgestrel and ethinyl estradiol tablets. The specific lot numbers are included in Pfizer's press release.

Women who have been using recalled product should begin using a nonhormonal form of contraception immediately, notify their physician and return the product to the pharmacy.

The FDA is asking health care professionals and patients to report any adverse events related to the use of these products to its MedWatch Safety Information and Adverse Event Reporting Program(www.fda.gov). Adverse events also may be reported to Akrimax toll-free at (877) 509-3935 from 8:00 a.m.-5:00 p.m. CST Monday through Friday.