Recalls / Class II
Class IID-205-2013
Product
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28
- Affected lot / code info
- Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
Why it was recalled
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
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
- 136,720 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-13
- FDA classified
- 2013-03-19
- Posted by FDA
- 2013-03-27
- Terminated
- 2014-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-205-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.