Drug Enforcement D-0536-2023

Failed Dissolution Specifications: Out of specification dissolution results above specified values.

Status

Terminated

Classification

Class II

Report Date

April 26, 2023

Termination Date

May 12, 2024

Product Information

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.
Product quantity
695 cartons
Reason for recall
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0536-2023
Event ID
91956
Recall initiation date
March 16, 2023
Center classification date
April 14, 2023
Code info
Lots: 1008622, 1010026, Exp 2/29/24
More code info
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