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1 Million Birth Control Pill Packs Recalled
2012-02-14
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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.