Estarylla FDA Alerts
The FDA Alert(s) below may be specifically about Estarylla or relate to a group or class of drugs which include Estarylla (ethinyl estradiol/norgestimate).
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/norgestimate
Estarylla (norgestimate and ethinyl estradiol): Recall - Report of Placebo Tablet Present in Row of Active Tablets
Jul 5, 2013
Audience: Pharmacy, Patient
ISSUE: Sandoz notified the public it is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US, following a customer report of a placebo tablet present in a row of active tablets on one pack.
The lot number, expiration date, and NDC code of the recalled lot is: LF01213A, expiration date 02/2014, NDC 00781-4058-15. It is supplied in cartons containing 3 blister cards of 28 tablets each. This lot was distributed to the US market only.
BACKGROUND: Estarylla is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
RECOMMENDATION: The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week.
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
[07/05/2013 - Press Release - Sandoz US]
Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen
Feb 27, 2012
Audience: OB/GYN, Pharmacy, Patient
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.]