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Tri-Previfem FDA Alerts

The FDA Alerts below may be specifically about Tri-Previfem or relate to a group or class of drugs which include Tri-Previfem.

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.

Recent FDA Alerts for Tri-Previfem

Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen

ISSUE: Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg), because 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 visible only on the outer pouch. 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.

BACKGROUND: Norgestimate and Ethinyl Estradiol Tablets are used as an oral contraceptive, indicated for the prevention of pregnancy in women. The product was distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. 

RECOMMENDATION: 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. See the Press Release for a listing of affected lot numbers, expiration dates, and product photos.

 

[02/24/2012 - Press Release - Glenmark Generics Inc.]


Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error

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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