We would like to inform you of the important Drug Recall on Norgestimate and Ethinyl Estradiol Tablets USP sent from Glenmark-Generics.
Glenmark-Generics is recalling seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. Glenmark Generics issued a voluntary, nationwide, consumer-level recall because of packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only in the outer pouch. Any blister for which the lot number and expiry date is not visible is subject to recall.
These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and are distributed by Glenmark Generics Inc.USA. This product was distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011.
Lot numbers of affected packs of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg, 0.035 mg, 0.25 mg/0.035 mg, (Generic) are as follows:
NDC Lot Nos Expiration
68462-565-29 04110101 7/31/2013
04110106 7/31/2013
04110107 7/31/2013
04110114 8/31/2013
04110124 8/31/2013
04110129 8/31/2013
04110134 9/30/2013
Any adverse events that may be related to the use of these products should be reported to Glenmark Generics, Inc., USA at 1-(888) 721-7115 (8 AM to 5 PM Mon-Fri EST) 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-addresses 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
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
Save 10% off your first purchase of 12 Bottles of Daily-Vites.
Folic Acid is a B vitamin that helps a baby's neural tube grow healthy during pregnancy. The neural tube will become a baby's brain and spinal cord. But if the neural tube doesn't close the way it should, it can cause a very serious birth defect called a neural tube defect (NTD).
Please contact your R&S Sales Representative for pricing.
Pennsylvania (800) 262-7770
Ohio (866) 994-7472
Kentucky (866) 228-9758
Public Release Date: 28-May-2009
Summary of "Intrauterine Devices for Adolescents: a Systematic Review," Deans/Grimes, Contraception, June 2009.
Adolescent pregnancy persists as a "stubborn" public health problem in the U.S., with teenagers accounting for nearly 750,000 pregnancies annually, about 82% of which are unintended. Although adolescents have higher continuation rates with longer-acting contraceptive methods, the majority of them use oral contraceptives and condoms. Adolescents' compliance with shorter-acting methods is mediocre, and many could benefit from methods that are simpler to use and longer-lasting, according to the researchers.
Public Release Date: 6-January-2009
Merck is seeking FDA approval for the use of its human papillomavirus vaccine, Gardasil, for boys and young men ages nine to 26, the Wall Street Journal reports. Merck is seeking the approval for the prevention of male genital warts and other lesions, for which Gardasil was shown effective in recent studies, according to a Merck spokesperson.
Continue reading "Merck Seeks FDA Approval for HPV Vaccine Use in Boys, Young Men"
URGENT
PRODUCT DISCONTINUATION
MODICON Clinic
September 30, 2008
Dear Customer:
Ortho Women’s Health & Urology is discontinuing the “clinic” package of MODICON NDC 00062-1714-20 effective immediately. The “trade” package of MODICON NDC 00062-1714-15 continues to be available and should be ordered in place of NDC 00062-1714-20.
DISCONTINUED
PRODUCT: MODICON CLINIC
NDC CODE: 00062-1714-20
PRODUCT DESCRIPTION: Veridate Dispenser Packs
AVAILABLE
PRODUCT: MODICON TRADE
NDC CODE: 00062-1714-15
PRODUCT DESCRIPTION: DIALPAK Dispenser Packs
We apologize for any inconvenience this may cause you. If there are any questions, please contact JOM Pharmaceutical Service’s Customer Service Department at:
800-631-5273.
Regards,
April Fisher
Strategic Business Group
Ortho-McNeil Janssen Pharmaceuticals, Inc.
We have great news for our members! Just in time for flu season and "Get Ready Day," our friends over at Anda have agreed to give Cooperative Purchasing Program members deep discounts on Afluria!
The price schedule looks like this:
10 dose Vial (5 ml) $82.35
10 pack Pre-fill syringe $113.95
Click HERE to access the order form!
Please call our Membership Coordinator, Julia Shebby, at 213-386-5614 x4558 or send an email to coop@cfhc.org for membership details.
Public Release Date: 31-July-2007
Synova Healthcare recently launched a new Web site and an advertising campaign to market the Today Sponge female contraceptive in the U.S., the New York Times reports (Levere, New York Times, 7/30).
The sponge, which is constructed of soft polyurethane foam and is inserted into the vagina for up to 24 hours, provides barrier protection and the spermicide nonoxynol-9 to prevent pregnancy. The device is 89% to 91% effective in preventing pregnancy but does not protect against sexually transmitted infections.
Continue reading "Synova Launches Advertising Campaign for Today Sponge Contraceptive "
Public Release Date: 9-May-2007
SAN DIEGO -- Those who battled the FDA for non-prescription status of Plan B (levonorgestrel) apparently won only half the struggle. Prescription or not, Plan B can be hard to get.
A survey of Plan B availability in three major cities found that state laws can override the ease of access to the emergency contraception agent, whether by prescription or "under-the-counter" sales.
Continue reading "ACOG: Plan B Availability Varies from State to State"