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Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-c...

FDA Recall #D-017-2013 — Class II — October 19, 2012

Recall #D-017-2013 Date: October 19, 2012 Classification: Class II Status: Terminated

Product Description

Necon 1/35-28 (norethindrone 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 Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880 USA; NDC 52544-552-28.

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

6,466 cartons

Distribution

Nationwide and Puerto Rico

Code Information

Lot #: 514743AB, Exp 09/30/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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