Family Matters

Pfizer Recalls 1 Million Birth Control Pills

Women with recalled packets are at greater risk of pregnancy and should use back-up contraception. Is your pill on the list?

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About 1 million packets of birth control pills are being recalled in the U.S. by Pfizer because a packaging mishap could increase the likelihood of pregnancy.

The affected pills include 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets. All the pills were marketed by Akrimax Rx Products and have expiration dates ranging from July 31, 2013, to March 31, 2014. They were distributed to warehouses, clinics and pharmacies throughout the U.S.

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Birth control pills typically contain 21 days of hormone-laden, or active, tablets and 7 days of placebo pills. But some of the recalled packets have too many active tablets while others don’t have enough, and some of the pills may be out of sequence.

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The problem, which has since been corrected, seems to have been caused by inspection failures. “As a result of this 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,” Pfizer said in a statement released Tuesday. “…Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately.”

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This is the second major contraceptive recall in less than six months. In September, Qualitest Pharmaceuticals recalled 1.4 million packages of birth control pills because of a different packaging error.

Women who have the recalled Pfizer tablets should contact their doctors and return the medication.

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According to the statement:

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 (8 AM to 7 PM Mon-Fri CST) or to FDA’s Med Watch Program.

Lot numbers of affected packs of Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) are reprinted here:

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

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