Qualitest pulls suspect OCs

Check your pharmacy stock, and review patient pill choices: A nationwide recall of multiple lots of Qualitest oral contraceptives (OCs) has been issued after the Huntsville, AL-based manufacturer detected a packaging error that could lead to incorrect administration of pills.

The voluntary, nationwide retail-level recall of the multiple lots was issued by the company Sept. 15, 2011. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals of Chadds Ford, PA.

Select blister packs were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible, according to information issued by the company. Products affected by the recall include Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20,  Orsythia, Previfem, and Tri-Previfem. A list of the lot numbers in question is available by accessing http://www.qualitestrx.com/pdf/OCRecall.pdf. Lot numbers may be checked by looking at the bottom of the product box or the individual blister card.

"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," states information released by the company. "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 and consult their health care provider or pharmacist."

Pharmacies have been instructed to contact consumers who have received affected product. Clinicians, pharmacists, or women seeking more information on this recall, or who have affected products, should contact Qualitest toll free at (877) 300-6153, from 8 a.m. to 5 p.m. Central Time Monday through Friday. Return of any affected product may be arranged by calling the toll-free number.

Adverse reactions or quality problems associated with the use of the affected products may be reported to Qualitest toll-free at (877) 300-6153 or to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by regular mail using a postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm, or by faxing the Form FDA 3500 to (800) 332-0178. (To check FDA recalls, see the Resource listing at the end of this story.)

Recalls happen

Family planning clinicians have experienced similar recalls in 2000 (Norplant contraceptive implant), 2002 (Lunelle contraceptive injection), and 2003 (Nortrel 7/7/7 OC).

The recall for the suspect lots of the Qualitest pills might not have as much as an impact on clinics, since the Qualitest pills are relatively new. The two most established Qualitest pills are Previfem, a generic equivalent to Ortho Cyclen, and Tri-Previfem, an equivalent to Ortho Tri-Cyclen. Both received FDA approval in 2004. FDA approvals followed in 2005 for Gildess (generic for Loestrin) and Gildess FE (equivalent to Loestrin FE). Cyclafem 1/35 (generic to Ortho Novum) and Cyclafem 7/7/7 (equivalent to Ortho Novum 7/7/7) gained approval in late 2010, with Emoquette (generic for Ortho-Cept) and Orsythia (equivalent to Alesse) approvals issued in 2011.


To review Food and Drug Administration (FDA) recalls, go to the FDA web site, www.fda.gov. On the lower right side of the page, click the "Recalls & Safety Alerts" link. Click on the "Drugs" tab to see all information on drugs. The database can be sorted by brand name and company. Citizens also can sign up for free recall, withdrawal, and safety alerts from the FDA on this same page.'