Drug product
Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
D-1403-2012
Product summary
- Event
- Event 62383
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,262 bottles
- Official record key
drug-enforcement:D-1403-2012
Official wording
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Code information: Lot # 22478A
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing