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Home » Santa Clarita News » Recalls » Birth Control Pills Recalled For Miscounted Packaging, Rice Crackers For Allergen

Birth Control Pills Recalled For Miscounted Packaging, Rice Crackers For Allergen

Recall-SidebarOral contraceptives and rice crackers are the subject of recalls by the US Food and Drug Administration today.

BIRTH CONTROL PILLS

RECALLBCpillsonePfizer 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.

RECALLBCpillstwoAs 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

 

RICE CRACKERS

RECALLricecrackersonePresident Global Corp., Buena Park, Gemini Food Corporation of City of Industry and Tong Enterprises of Hayward are recalling all codes of Bin-Bin Snow Rice Cracker net weight 5.3oz (150g) and Bin-Bin Rice Crackers net weight 15.8oz (450g) because of undeclared egg allergens. People who have an allergy or severe sensitivity to eggs, run the risk of suffering serious or life-threatening reactions if they consume this product.

Product:

Bin-Bin Snow Rice Crackers 5.3oz (150g)

Codes:

All Codes

UPC Code:

8852098700124

Product:

Bin-Bin Rice Crackers 15.8oz (450g)

Codes:

All Codes

UPC Code:

8852098701510

RECALLricecrackerstwoBin-Bin Snow Rice Cracker and Bin-Bin Rice Crackers contain eggs which are not declared on the back label.

The product was distributed to grocery stores by President Global Corp nationwide between January 1st 2011 and January 31st 2012.

There has been one reported allergic reaction associated with the consumption of this product.

Consumers who have purchased the items listed above are urged to return it to the place of purchase for a full refund. Consumers who have health-related concerns should contact their physician. Consumers with questions may contact President Global Corp. at 1-714-994-2990, Monday – Friday, 9a.m.-6p.m. Pacific Time.

 

Birth Control Pills Recalled For Miscounted Packaging, Rice Crackers For Allergen

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