Recalls / Class II
Class IID-015-2013
Product
Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 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., Corona, CA 92880 USA; NDC 52544-953-28.
- Affected lot / code info
- Lot #: 514767AA, Exp 03/31/14
Why it was recalled
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
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 311 Bonnie Cir, N/A, Corona, California 92880-2882
Distribution
- Quantity
- 12,333 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-10-19
- FDA classified
- 2012-10-24
- Posted by FDA
- 2012-10-31
- Terminated
- 2013-11-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-015-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.