Why it was recalled
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Product description
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
Lot numbers, UPCs & expiration codes
Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-205-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 13, 2013
- FDA report date
- Mar 27, 2013
- Quantity
- 136,720 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-205-2013, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64358
- Address
- 311 Bonnie Cir
- Code information
- Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
- Postal code
- 92880-2882
- Report date
- Mar 27, 2013
- Product type
- Drugs
- Recall number
- D-205-2013
- Classification
- Class II
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 136,720 cartons
- Termination date
- Jan 31, 2014
- Reason for recall
- Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2013