Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral®-28 And Norgestrel/Ethinyl Estradiol Tablets Due To Possibility Of Inex

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

 


NEW YORK--(BUSINESS WIRE)--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.

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.htm1
 

 

Regular Mail:
 

 

 

Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. 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

 

 

Contacts


 Pfizer Inc.
Grace Ann Arnold - Media
(845) 602-4768
[email protected]


 

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