Qualitest Pharmaceuticals has issued a nationwide, retail-level recall of multiple lots of oral contraceptives. The recall was because of a packaging error. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots.
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. The company says these packaging defects do not pose any immediate health risks. However, it says consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist.
Pharmacies are being instructed to contact consumers who have received the affected product. The source of the error is currently under investigation and the company says it’s committed to rectifying the issue in a timely manner.
The affected products and lot numbers can be found at the following URL: http://www.qualitestrx.com/pdf/OCRecall.pdf. You may also contact Shanna Malone for this information at Shanna.Malone@beasleyallen.com. Doctors, pharmacists or women seeking additional information on this recall, or consumers who have affected products, should contact Qualitest toll free at 1-877-300-6153 between the hours of 8:00 a.m. and 5:00 p.m. CT Monday through Friday for information or to arrange return of any affected product. The lot numbers can be found on the bottom of the box or the individual blister card. Adverse reactions or quality problems experienced with the use of these products may be reported to Qualitest toll free at 1-877-300-6153 or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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