Recalls / Class III
Class IIID-0996-2019
Product
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
- Brand name
- Oxybutynin Chloride
- Generic name
- Oxybutynin Chloride
- Active ingredient
- Oxybutynin Chloride
- Route
- Oral
- NDCs
- 62175-270, 62175-271, 62175-272
- FDA application
- ANDA078503
- Affected lot / code info
- Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Lannett Company Inc.
- Manufacturer
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- N/A
- Address
- 1101 C Ave W, N/A, Seymour, Indiana 47274-3342
Distribution
- Quantity
- 14,448 bottles
- Distribution pattern
- Nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2019-02-21
- FDA classified
- 2019-03-12
- Posted by FDA
- 2019-03-20
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0996-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.