Birth control pills recalled |
The problems seems to be a quality control screw up as some packets were found to contain too many active tablets, while others had too few. According to Pfizer, these packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging are advised to begin using a non-hormonal form of contraception immediately.
The product recalled are Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic). Lot numbers of affected packs are listed on the FDA’s website,
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.
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
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
---------
Source
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
|