from
http://www.fda.gov/Safety/Recalls/ucm289770.htm
Recall
-- Firm Press Release
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posts press releases and other notices of recalls and market
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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@Pfizer.com
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 |
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