Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Pfizer Announces Voluntary Nationwide Recall of Lo/Ovral®-28
and Norgestrel/Ethinyl Estradiol Tablets Due to
Possibility of Inexact Tablet Counts or Out of Sequence Tablets
Contact:
Consumer:
1-877-509-3935
Media:
Grace Ann Arnold – Media
(845) 602-4768
Graceann.Arnold@xxxxxxxxxx
FOR IMMEDIATE RELEASE - January 31, 2012 - NEW YORK, N.Y. – Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. The cause was identified and corrected immediately.
These products are oral contraceptives indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. These tablets were manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. This product is distributed to warehouses, clinics and retail pharmacies nationwide.
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. Correctly packaged blister packs are pictured here.
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 either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.htm
Regular Mail: Use postage-paid, pre-addressed Form FDA 3500
available at: www.fda.gov/MedWatch/getforms.htm. Mail
to the address on the pre-addressed form.
Fax: 1-800-FDA-0178
Pfizer has responded rapidly to ensure that its products continue to meet the company’s high quality standards. The safety of patients who take our medicines is our first priority.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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 |
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
