D-0996-2019 Class III Terminated
FDA drug recall D-0996-2019 was initiated by Lannett Company Inc. on February 21, 2019 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated November 6, 2020). Affected quantity: 14,448 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2019
- Initiation Date
- February 21, 2019
- Termination Date
- November 6, 2020
- Voluntary/Mandated
- N/A
- Product Quantity
- 14,448 bottles
Product Description
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide, including Puerto Rico.
Code Information
Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021