Drug recall: Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC…
Class III FDA enforcement event 62383. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Watson Laboratories Inc started this drug recall on 17 Apr 2012. The firm address in the FDA record is in Corona, CA. FDA put the recall in Class III. FDA event 62383 has 5 product records. The first FDA enforcement report date is 11 Jul 2012. The record gives the status Terminated, with the termination date 18 Mar 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide.
Recalling firm
Watson Laboratories Inc, Corona, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1399-2012 | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. | 8254 bottles | Class III | Terminated | 11 Jul 2012 |
| D-1400-2012 | Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 | 106,323 bottles | Class III | Terminated | 11 Jul 2012 |
| D-1401-2012 | Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 | 21,572 bottles | Class III | Terminated | 11 Jul 2012 |
| D-1402-2012 | Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 | 18,902 bottles | Class III | Terminated | 11 Jul 2012 |
| D-1403-2012 | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 | 7,262 bottles | Class III | Terminated | 11 Jul 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2012
- 209
- Share of these events in Class III
- 28%
- Product records in this event
- 5Median of the firm: 1
- Events of the firm on the register
- 13
Other events of the firm
Official channels
- FDA enforcement report D-1399-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 62383. https://recallregister.com/fda/iii/62383/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide.
- What quantity of product is in FDA event 62383?
- The event has 5 product records. The first record gives this quantity:
8254 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2012 have the same class?
- 28% of the 209 drug events that started in 2012 are in Class III.