Drug recall: Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc…
Class III FDA enforcement event 82144. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Failed Dissolution Specifications
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
Lannett Company Inc. started this drug recall on 21 Feb 2019. The firm address in the FDA record is in Seymour, IN. FDA put the recall in Class III. FDA event 82144 has 1 product record. The first FDA enforcement report date is 20 Mar 2019. The record gives the status Terminated, with the termination date 6 Nov 2020.
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, including Puerto Rico.
Recalling firm
Lannett Company Inc., Seymour, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: N/A.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0996-2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37 | 14,448 bottles | Class III | Terminated | 20 Mar 2019 |
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 2019
- 362
- Share of these events in Class III
- 22%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 14
Other events of the firm
Official channels
- FDA enforcement report D-0996-2019The 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.
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Cite this page
Recall Register. FDA enforcement event 82144. https://recallregister.com/fda/iii/82144/. 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, including Puerto Rico.
- What quantity of product is in FDA event 82144?
- The FDA record gives this quantity:
14,448 bottles
- How many drug recalls of 2019 have the same class?
- 22% of the 362 drug events that started in 2019 are in Class III.
- How many FDA recalls does Lannett Company Inc. have?
- Lannett Company Inc. is the recalling firm in 14 enforcement events on this register. This event is 1 of them.