D-0536-2023 Class II Terminated
FDA drug recall D-0536-2023 was initiated by Amerisource Health Services LLC on March 16, 2023 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification dissolution results above specified values. The recall status is terminated (terminated May 12, 2024). Affected quantity: 695 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- April 26, 2023
- Initiation Date
- March 16, 2023
- Termination Date
- May 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 695 cartons
Product Description
Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.
Reason for Recall
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 1008622, 1010026, Exp 2/29/24