Drug product
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.
D-014-2013
Product summary
- Event
- Event 63509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67,860 cartons
- Official record key
drug-enforcement:D-014-2013
Official wording
Reason: 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).
Code information: Lot #: 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, 517923AB, Exp 03/31/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
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).