The Federal Drug Enforcement Agency announced Wednesday two birth control brands made by Pfizer Inc. have been voluntarily recalled because of the possibility the packs may contain an inexact count of inert or active ingredient tablets.
The recalled 14 lots of Lo/Ovral-28 Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets, the generic form for customers in the U.S. market, may also be out of sequence, according to an FDA press release.
When properly packaged, the pills are placed in blister packs containing 21 tablets of active ingredients and seven tables of inert ingredients.
“As a result of the packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception and at risk for unintended pregnancy,” said Grace Ann Arnold, media spokeswoman for Pfizer.
She said these packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately.
“Patients who have the affected product should notify their physician and return the product to the pharmacy,” she said.
Arnold said 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 or to the FDA Medical Watch Program. |
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