Following is a Pfizer generated document we received on Friday, January 13, 2012:
Pfizer Inc. is recalling multiple lots of LO/OVRAL - 28 Tablets and Norgestrel 0.3mg/Ethinyl Estradiol 0.03mgTablets manufactured and packaged by Pfizer, and distributed and commercialized by Akrimax Pharmaceuticals, LLC (see below for lot numbers and expiration dates). Please note that these products are labeled with Akrimax labeling. Pfizer Inc. voluntarily initiated this recall when it was determined that some blister packs may contain an inexact count of placebo or active ingredient tablets. Please note that use of this product is not likely to cause adverse health consequences.
FEDERAL REGULATIONS REQUIRE THAT YOU RESPOND TO THIS RECALL, EVEN IF YOU DO NOT HAVE THE RECALLED PRODUCT. TO RESPOND, PLEASE CONTACT STERICYCLE INC. AT 1(800)-805-3093 WITHIN FIVE (5) BUSINESS DAYS.
The recall of LO/OVRAL - 28 Tablets and Norgestrel 0.3mg/Ethinyl Estradiol 0.03 mg Tablets is being conducted to the retail level.
Records indicate that you may have received shipment of affected lots between January 2011 and December 2011. Please check your stock immediately against the table below. If you have any of the affected products in your inventory, please stop distribution and promptly return to Stericycle Inc. 2670 Executive Drive, Suite A Indianapolis, IN 46241: Attn: Event 2568. Please contact Stericycle Inc. at (800) 805-3093 if you require the pre-paid UPS labels. If you have any medical inquiries regarding these products, please contact Akrimax Medical Information at 1(877)509-3935 (8 AM to 7 PM Mon-Fri CST).
If you have further distributed the lots to the retail level, please conduct a sub-recall and communicate this recall information to those accounts immediately. Please request that they immediately cease distribution of the affected lots and promptly return the product directly to the above address. If they have inventory of the affected product, they can contact Stericycle Inc. at (800) 805-3093 to obtain pre-paid shipping labels for product return. Further authorization is not required for product return. Reimbursement for the returned product will be made by credit memorandum. If you have any questions regarding the reimbursement, please contact your Akrimax Customer Service Representative at 1(877) 509-3935 (8 AM to 7 PM Mon-Fri CST).
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. We appreciate your immediate attention and cooperation to this matter.
LO/OVRAL® - 28
LOT# Expiration Date
E15678 8/31/2013
E15679 8/31/2013
E15686 8/31/2013
E15687 1/31/2014
E15690 1/31/2014
E15698 1/31/2014
E15700 2/28/2014
E80434 7/31/2013
E80438 8/31/2013
F36908 2/28/2014
F36909 2/28/2014
F43915 3/31/2014
F43926 3/31/2014
F43927 3/31/2014
NORGESTREL 0.3MG/ETHINYL ESTRADIOL 0.03 MG
LOT# Expiration Date
E15677 8/31/2013
E15704 1/31/2014
E15706 1/31/2014
E80440 8/31/2013
F16388 1/31/2014
F16390 2/28/2014
F22132 2/28/2014
F31330 2/28/2014
F36911 3/31/2014
F36913 3/31/2014
F43924 3/31/2014
F43925 3/31/2014
F43934 3/31/2014
F53238 3/31/2014
We hope you all had a wonderful holiday weekend! We have one more week left till the new year, and one more great coupon from Office Depot. Here's the Week 5 deals from Office Depot's Hot Holiday deals! Hurry - these offers are good through 12/31/11!
Valid in-store only.Must present this ad to cashier at time of purchase. Not combinable with your Store Purchasing Card. Hurry, these offers end on 12/31/11!
For more information or to receive the ad, please visit our website http://www.fpcpp.org/ or email coop@cfhc.org.
There is still time for you to pick up that last minute gift! Here is the week 4 HOT Holiday deals from Office Depot. Hurry, these offers are good through 12/24/11!
Valid in-store only.Must present this ad to cashier at time of purchase. Not combinable with your Store Purchasing Card. Hurry, these offers end on 12/24/11!
For more information or to receive the ad, please visit our website http://www.fpcpp.org/ or email coop@cfhc.org.
Here's the Week 3 deals from Office Depot's Hot Holiday deals! Hurry - these offers are good through 12/17/11!
Valid in-store only. Must present this ad to cashier at time of purchase. Not combinable with your Store Purchasing Card. Hurry, these offers end on 12/17/11!
For more information or to receive the ad, please visit our website http://www.fpcpp.org/ or email coop@cfhc.org.
"The man is happiest who lives from day to day and asks no more, garnering the simple goodness of life." ~ Euripides
LOS ANGELES/BERKELEY, CA – December 7, 2011 – Dr. Margaret Hamburg, the Commissioner of the United States Federal Drug Administration (FDA) announced today that Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) overruled the FDA’s decision to allow Plan B One-Step, emergency contraceptive pills, to be available without a prescription for all ages.
Plan B One-Step received approval in 2006 to be accessible without a prescription for females 17 and older and only available to those younger than 17 with a prescription. In February 2011, Teva Women’s Health Inc, submitted a request to remove the age restriction on their product based on studies they had performed that provided scientific evidence that Plan B One-Step was safe and effective for all ages. The Center for Drug Evaluation and Research (CDER) was tasked with reviewing Plan B One-Step for over-the-counter use and determined that the product could indeed be used properly by adolescent females without an intervention from a health care provider.
Based on the data, evidence and recommendation from CDER experts including obstetricians, gynecologists, and pediatricians, the FDA was set to approve Plan B One-Step for all females of child-bearing age until the surprise move this morning by HHS to intervene.
“Today’s announcement comes as a big shock and disappointment,” said Julie Rabinovitz, President and CEO of California Family Health Council. “Secretary Sebelius’ decision to reverse the FDA’s charted course to approve Plan B One-Step for over-the-counter use without an age restriction flies in the face of science. For the past few years the public health community has been feeling a certain sense of relief that the FDA had returned to making decisions based on sound scientific evidence and not politics. It’s worrisome that under the current administration, that might not entirely be the case,” added Rabinovitz.
Emergency contraception is just one of a broad range of contraceptive options in use by teens today. In fact, teen births are at an all time low and research suggests that the decline is linked almost exclusively to a dramatic shift in teen contraceptive use. According to a report by the Guttmacher Institute, there has been an increase in teens’ use of contraceptives overall and in their use of dual methods to protect against pregnancy and STI transmission. Still, there is considerable room for improvement. The National Survey of Family Growth reports that nearly one in five female teens at risk of unintended pregnancy were not using any contraceptive method at last intercourse.
“In order for emergency contraception to be used as intended—in an emergency—we need to make sure teens have access to every tool in the pregnancy prevention toolbox. This means access to comprehensive, affordable reproductive health services, including emergency contraception and longer-term birth control. Through this surprising action the Obama administration has failed to break down a barrier to access for teens that was on track to be eliminated,” Rabinovitz said.
For more information on the California Family Health Council, visit http://cfhc.org.
Did you see the news this morning? The FDA wants to lift the age limit and provide Plan B to anyone at any age, without a prescription and sold over the counter. Some people see this as a victorious movement, and others are offended! There are still many misconceptions out there on Plan B, but hopefully we can all learn a thing or two from this debate.
Check out the debate provided by Fox News by clicking here.
Yale Cancer Center researchers have shown that a tiny genetic variation predicts chances of survival and response to treatment for patients with ovarian cancer.
The findings, published in the journal Oncogene, provide new insights into the biology of a new class of cancer marker and suggest a genetic test may help guide the treatment of women with ovarian cancer.
"This gives us a way to identify which women are at highest risk for resistance to platinum chemotherapy, the standard treatment for ovarian cancer, and helps identify ovarian cancer patients with the worst outcomes," said Joanne Weidhaas, associate professor of therapeutic radiology and senior author of the study. "There just aren't many inherited gene variants than can do that."
Women who possess the biomarker identified by the Yale team – a variant of the well-known KRAS oncogene – are three times more resistant to standard platinum chemotherapy than women without the variant. Also, post-menopausal women with the variant are significantly more likely to die from ovarian cancer. About 12-15 percent of Caucasians and 6 percent of African-Americans are born with the variant of the gene, which helps regulate destruction of damaged cells. This variant is found in up to 25% of newly diagnosed ovarian cancer patients.
Although good alternatives to chemotherapy are not yet available for women with ovarian cancer and this variant, several drugs in development which target the KRAS gene and associated pathways have shown great promise, Weidhaas said.
Weidhaas is a co-founder of a company that has licensed intellectual property from Yale that has developed a diagnostic test based on the Kras-variant.
The biomarker intrigues scientists because it is a functional variant in an area of DNA that does not code for proteins. Instead this variant disrupts how a microRNA controls gene expression.
"This is a new paradigm," Weidhaas said.
Yale researchers have also found this microRNA variant of the KRAS gene is associated with an increased risk of developing breast cancer and lung cancer. Other researchers have found associations with poor outcome in colon as well as head and neck cancers.
In laboratory tests, researchers blocked the variant and significantly reduced growth of ovarian cancer cells. This suggests targeting the variant site may someday help treat cancer in these patients.
Posted thanks to kind permission from our friends at EurekAlert!, a service of AAAS.
Here's the Week 2 deals from Office Depot's Hot Holiday deals! Hurry - these offers are good through 12/10/11!
Valid in-store only. Must present this ad to cashier at time of purchase. Not combinable with your Store Purchasing Card. Hurry, these offers end on 12/10/11!
For more information or to receive the ad, please visit our website http://www.fpcpp.org/ or email coop@cfhc.org.