Drug 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
D-0996-2019
Product summary
- Event
- Event 82144
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,448 bottles
- Official record key
drug-enforcement:D-0996-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021
Distribution pattern: Nationwide, including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications