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Oral Contraceptives' Packaging Error Prompts Pfizer Recall
Incorrect Daily Regimen Could Pose Pregnancy Risk
By News Staff
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. 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.