Drug product
Zovia (ethynodiol diacetate 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 Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-383-28.
D-013-2013
Product summary
- Event
- Event 63509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,267 cartons
- Official record key
drug-enforcement:D-013-2013
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 #: 515622AA, 515623AA, and 515623BA, Exp 09/30/13
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).