FDA recall D-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.

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

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-10-19

Report date

2012-10-31

Termination date

2013-11-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-015-2013