FDA Drug recall D-1399-2012
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01
- FDA Drug
- Class III
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class III recall of Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01 by Watson Laboratories, citing labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1399-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-04-17 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories |
| Distribution | US |
Product
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Reason
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Identifiers
| code_info | Lot 108094A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1399-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.