| TO: | DDS Regional Directors, STS Director, CTH Coordinators, Private Providers, CO Quality Management Personnel |
| FROM: | Daniel A. Micari, Director, Quality Management Services |
| DATE: | February 6, 2012 |
| RE: | Product Recall Advisory - Pfizer Announces Voluntary Nationwide Recall of Lo/Ovral®-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets |
Drug Product Recall Advisory
U.S. Dept. of Health and Human Services and the U.S. Food and Drug Administration - January 31, 2012 - NEW YORK, N.Y. – Pfizer 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.
As 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 should notify their physician and return the product to the pharmacy.
For further information please refer the attached PDF document.
Pfizer Recall (PDF, 88 KB)
Please ensure those responsible are aware of this important drug product recall. Please distribute this information throughout your organization and contacts.