Recalls / Class III
Class IIID-1403-2012
Product
Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
- Affected lot / code info
- Lot # 22478A
Why it was recalled
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
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
- 7,262 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-04-17
- FDA classified
- 2012-06-29
- Posted by FDA
- 2012-07-11
- Terminated
- 2013-03-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1403-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.