Drug product
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
D-1401-2012
Product summary
- Event
- Event 62383
- Status
- Terminated
- Classification
- Class III
- Quantity
- 21,572 bottles
- Official record key
drug-enforcement:D-1401-2012
Official wording
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Code information: Lot #s: 101696A, 110829A, 123685A, 123687A
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing