Wednesday, February 1, 2012

Pfizer’s recalls out of control birth control pills

Birth control pills recalled
Pfizer has recalled 1 million birth control pills in the US because they may not do what they were supposed to do. It appears the pills may not contain enough contraceptive to be effective in pregnancy prevention.

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

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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