Drug 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
D-205-2013
Product summary
- Event
- Event 64358
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136,720 cartons
- Official record key
drug-enforcement:D-205-2013
Official wording
Reason: Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Code information: Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .