Status
Terminated
Drug Enforcement D-014-2013
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).
Classification
Class II
Report Date
October 31, 2012
Termination Date
November 21, 2013
Product Information
- 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.
- Product quantity
- 67,860 cartons
- 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).
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Watson Laboratories Inc
- Address
-
311 Bonnie Cir, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-014-2013
- Event ID
- 63509
- Recall initiation date
- October 19, 2012
- Center classification date
- October 24, 2012
- Code info
- Lot #: 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, 517923AB, Exp 03/31/14
- More code info
- —