KENTUCKY (2/1/12) – The Internationally known medical product manufacturer, Pfizer, has issued an voluntary recall of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States.
According to Pfizer representatives, “Recently, it came to our attention that there may be an issue with the way some of these pills were packaged…and that the inactive or placebo pill may have been placed out-of-order in some packs. Upon discovery of the issue, we took corrective action and notified the FDA. Based on our own rigorous internal assessments of this problem, we believe there are approximately 30 packs of birth control pills that may have received an inexact count or inactive tablet.”
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. 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 (lot numbers are provided below) should notify their physician and return the product to the pharmacy.
These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy.
Pfizer stated that they have recalled approximately 1 million pacts to ensure that any possibly impacted product is removed from pharmacy shelves.
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
SurfKY News
Information provided by Pfizer Inc.
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