D-0436-2023 Class II Terminated
FDA drug recall D-0436-2023 was initiated by Amerisource Health Services LLC on January 27, 2023 and is designated Class II. Reason for recall: Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values. The recall status is terminated (terminated May 12, 2024). Affected quantity: 422 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2023
- Initiation Date
- January 27, 2023
- Termination Date
- May 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 422 cartons
Product Description
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 1009065, Exp 12/31/2023