Qualitest Pharmaceuticals has issued a nationwide, retail-level recall of multiple lots of oral contraceptives. The recall is the result of a 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 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.
The recall is effective immediately and includes the following products:
- Cyclafem™ 7/7/7
- Cyclafem™ 1/35
- Gildess® FE 1.5/30
- Gildess® FE 1/20
- Previfem ®
The affected lot numbers are available on the following website: http://www.qualitestrx.com/pdf/OCRecall.pdf
Because 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 using product with 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 affected product.
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.
The public is encouraged to report any adverse events that may be related to the use of this product to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The Monterey County Health Department releases notices of recalls and market withdrawal from the firms involved as a service to Monterey County residents, the media and other interested parties. The Health Department does not endorse either the product or the company.