D-0990-2019 Class III Terminated
FDA drug recall D-0990-2019 was initiated by AVKARE Inc. on March 1, 2019 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated January 14, 2020). Affected quantity: a) 2947 and b) 3379.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2019
- Initiation Date
- March 1, 2019
- Termination Date
- January 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 2947 and b) 3379
Product Description
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide.
Code Information
Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020