Drug product
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
D-1402-2012
Product summary
- Event
- Event 62383
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18,902 bottles
- Official record key
drug-enforcement:D-1402-2012
Official wording
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Code information: Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing