Multi event Drug Recall Enforcement Report Class III voluntary initiated by Watson Laboratories Inc, originally initiated on 04-17-2012 for the product Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 The product was recalled due to labeling: incorrect or missing package insert: an outdated version of a patient outsert was used when packaged.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
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By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Terminated |
| D-1399-2012 | 04-17-2012 | 07-11-2012 | Class III | 8254 bottles | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Terminated |
| D-1403-2012 | 04-17-2012 | 07-11-2012 | Class III | 7,262 bottles | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | 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By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | 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 NDC # 0591-0370-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Terminated |
Recalled Products
