An Important Drug Recall - LO/OVRAL-28 and Norgestrel 0.3mg/Ethinyl Estradiol 0.03mg Tablets
January 17, 2012
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
