Important news for women using oral birth control products. Pfizer is recalling about one million packets of birth control pills in the United States because they may not contain enough contraceptive to prevent pregnancy.
"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," according to a Pfizer statement on the U.S. Food and Drug Administration website.
Monthly doses contain 28 tablets total... 21 with contraceptive and 7 sugar pills. The pharamceutical company discovered that some of their blister packs had too many active tablets, some had too few and some had the tablets out-of-order.
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The recall involves 14 lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets.
Pfizer said the mix-up poses no health threat to women, but it urges those taking the affected products to "begin using a non-hormonal form of contraception immediately."
A company spokesperson told The Associated Press that the problem is the result of both mechanical error and a failure on the packaging line during visual inspections.
The pills in question were distributed nationwide.
Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:
| 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 |
http://www.fda.gov/Safety/Recalls/ucm289770.htm
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