FDA Recall Loxapine
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Loxapine with NDC 0591-0369 was initiated on 04-17-2012 as a Class III recall due to labeling: incorrect or missing package insert: an outdated version of a patient outsert was used when packaged. The latest recall number for this product is D-1401-2012 and the recall is currently terminated as of 03-18-2013 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1401-2012 | 04-17-2012 | 07-11-2012 | Class III | 21,572 bottles | Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 | Terminated |
| D-1402-2012 | 04-17-2012 | 07-11-2012 | Class III | 18,902 bottles | Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 | Terminated |
| D-1400-2012 | 04-17-2012 | 07-11-2012 | Class III | 106,323 bottles | Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.