Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-co...
FDA Recall #D-013-2013 — Class II — October 19, 2012
Product Description
Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-383-28.
Reason for Recall
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Recalling Firm
Watson Laboratories Inc — Corona, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
30,267 cartons
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 515622AA, 515623AA, and 515623BA, Exp 09/30/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated