Recalls / Class III
Class IIID-1402-2012
Product
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
- Brand name
- Loxapine
- Generic name
- Loxapine
- Active ingredient
- Loxapine Succinate
- Route
- Oral
- NDCs
- 0591-0369, 0591-0370, 0591-0371, 0591-0372
- FDA application
- ANDA072204
- Affected lot / code info
- Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A
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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 311 Bonnie Cir, N/A, Corona, California 92880-2882
Distribution
- Quantity
- 18,902 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-1402-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.