Reported Mar 27, 2013 · Terminated

ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf.…

Watson Laboratories Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Watson Laboratories Inc · 311 Bonnie Cir · Corona, CA · 92880-2882

Is this the product you have?

ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by

3 of 3 products

Products covered by this recall
#Product as published
1Watson Laboratories, Inc., Corona, CA 92880. USA
2Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton
3NDC 52544-981-28
Lot codes and dates
    • Lot #s: 401536AA/401536A
    • 401537AA/401537/A
    • 401538AA/401538/A
    • 406985AA/406985A
    • 432058AA/432058A
    • 512685AA/512685A
Amount recalled
136,720 cartons

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 31, 2014 · Data as of Sep 19, 5:56 PM UTC

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