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1 Million Birth Control Pill Packs Recalled

Pregnancy Risk With Lo/Ovral-28, Generic Norgestrel/Ethinyl Estradiol

By Daniel J. DeNoon
WebMD Health News

Reviewed By Laura J. Martin, MD

Feb. 1, 2012 -- Pfizer has recalled 1 million packs of Lo/Ovral-28 and generic norgestrel/ethinyl estradiol birth control pills.

The pills, which must be taken in the correct sequence, may be mixed up. Women using the products risk pregnancy and should consult their doctors.

Although the pills are made and packaged by Pfizer, they are sold by Akrimax Rx Products and carry the Akrimax name on their labels.

The recall includes 14 lots of brand-name birth control pills and 14 lots of generic birth control pills distributed across the U.S.

The pills come in blister packs of 28 pills from which each dose must be taken in sequence. A Pfizer investigation found that some packs have the wrong number of pills, and the pills may be out of order.

Each pack normally contains 21 white pills with an active ingredient and seven pink pills that are inert. But women who take inert pills on days they should be taking active ones may not get the contraceptive effect they want, and should be aware of the signs of early pregnancy.

Other than pregnancy, the recalled pills have no health risks other than those usual for the product.

Pfizer has corrected the error. Meanwhile, the following product lots are being recalled:

NDC

Product

Lot

Expiration

Configuration/Count

24090-801-84

LO/OVRAL® 28

E15678

08/31/2013

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E15679

08/31/2013

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E15686

08/31/2013

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E15687

01/31/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E15690

01/31/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E15698

01/31/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E15700

02/28/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E80434

07/31/2013

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

E80438

08/31/2013

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

F36908

02/28/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

F36909

02/28/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

F43915

03/31/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

F43926

03/31/2014

6 Pilpacks® of 28 tablets each

24090-801-84

LO/OVRAL® 28

F43927

03/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

E15677

08/31/2013

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

E15704

01/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

E15706

01/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

E80440

08/31/2013

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F16388

01/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F16390

02/28/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F22132

02/28/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F31330

02/28/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F36911

03/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F36913

03/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F43924

03/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F43925

03/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F43934

03/31/2014

6 Pilpacks® of 28 tablets each

24090-961-84

Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg

F53238

03/31/2014

6 Pilpacks® of 28 tablets each

Women who have used the products should notify their doctors and return the products to their pharmacies.

SOURCES:

News release, FDA.

News release, Pfizer.

© 2012 WebMD, LLC. All rights reserved.



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