D-016-2013 Class II Terminated

Recalled by Watson Laboratories Inc — Corona, CA

Recall Details

Product Type
Drugs
Report Date
October 31, 2012
Initiation Date
October 19, 2012
Termination Date
November 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,684 cartons

Product Description

Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 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 52544-554-28.

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).

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot # 512642B, Exp 08/31/13