Drug recall
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA…
FDA recall event 62383 · Class III · Watson Laboratories Inc
Key facts
| Event ID | 62383 |
|---|---|
| Recall numbers | D-1399-2012, D-1400-2012, D-1401-2012, D-1402-2012, D-1403-2012 |
| Recalling firm | Watson Laboratories Inc |
| Product type | Drugs |
| Products | Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01, Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01, Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01, Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01., Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. |
| Initiation date | Apr 17, 2012 |
| Report date | Jul 11, 2012 |
| Termination date | Mar 18, 2013 |
| City | Corona |
| State | CA |
| Country | United States |
| FEI number | 2024830 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: