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Recall Observatory FDA recall evidence

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

October 19, 2012

Class II

Product summary

Firm
Watson Laboratories Inc
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

    reason.no_named_rule · v1.0.0

    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).