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Gildess Fe 1.5/30 FDA Alerts

The FDA Alert(s) below may be specifically about Gildess Fe 1.5/30 or relate to a group or class of drugs which include Gildess Fe 1.5/30 (ethinyl estradiol/norethindrone).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for ethinyl estradiol/norethindrone

Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error

Sep 16, 2011

Audience: Consumer, Pharmacy, OB/GYN

includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, Tri-Previfem

ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. 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.

BACKGROUND: These packaging defects do not pose any immediate health risks. Pharmacies are being instructed to contact consumers who have received affected product.

RECOMMENDATION: Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist. Consumers who have affected products should contact Qualitest for information or to arrange return of any affected product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[09/15/2011 - Press Release - Qualitest Pharmaceuticals]

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