Recalls / Class II
Class IID-66360-001
Product
Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.
- Affected lot / code info
- Lot#: 580974AA and 580975AA. Exp: 09/14
Why it was recalled
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 132 Business Center Dr, N/A, Corona, California 92880-1724
Distribution
- Quantity
- 1,002,394 tablets
- Distribution pattern
- US. No international. NATIONWIDE
Timeline
- Recall initiated
- 2013-09-23
- FDA classified
- 2013-10-09
- Posted by FDA
- 2013-10-16
- Terminated
- 2014-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66360-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.