D-014-2013 Class II Terminated
FDA drug recall D-014-2013 was initiated by Watson Laboratories Inc on October 19, 2012 and is designated Class II. 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). The recall status is terminated (terminated November 21, 2013). Affected quantity: 67,860 cartons.
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
- 67,860 cartons
Product Description
Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, 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., Parsippany, NJ 07054 USA; NDC 52544-949-28.
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 #: 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, 517923AB, Exp 03/31/14