Information on the recall of Lo-Ovral birth control pills by Pfizer Inc.

 

ISSUE: Pfizer Inc. notified healthcare professionals and consumers that it 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. 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.

BACKGROUND: These products are oral contraceptives indicated for the prevention of pregnancy. 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.

RECOMMENDATION: Patients who have the affected product should notify their physician and return the product to the pharmacy. See the Press Release for a list of affected lot numbers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1 Download form 2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Lot numbers of affected packs of Lo/OvralR-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/OVRALR 28 E15678 08/31/2013 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E15679 08/31/2013 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E15686 08/31/2013 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E15687 01/31/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E15690 01/31/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E15698 01/31/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E15700 02/28/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E80434 07/31/2013 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 E80438 08/31/2013 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 F36908 02/28/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 F36909 02/28/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 F43915 03/31/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 F43926 03/31/2014 6 PilpacksR of 28 tablets each
24090-801-84 LO/OVRALR 28 F43927 03/31/2014 6 PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E15677 08/31/2013 6
PilpacksR of 28 tablets each 24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E15704 01/31/2014 6
PilpacksR of 28 tablets each 24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E15706 01/31/2014 6 PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E80440 08/31/2013 6
PilpacksR of 28 tablets each

24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F16388 01/31/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F16390 02/28/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F22132 02/28/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F31330 02/28/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F36911 03/31/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F36913 03/31/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F43924 03/31/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F43925 03/31/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F43934 03/31/2014 6
PilpacksR of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F53238 03/31/2014 6
PilpacksR of 28 tablets each