Drug product
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
D-1400-2012
Product summary
- Event
- Event 62383
- Status
- Terminated
- Classification
- Class III
- Quantity
- 106,323 bottles
- Official record key
drug-enforcement:D-1400-2012
Official wording
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Code information: Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing