Drug Enforcement D-0169-2023

Failed Dissolution Specification

Status

Terminated

Classification

Class II

Report Date

February 1, 2023

Termination Date

August 15, 2024

Product Information

Product description
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.
Product quantity
49,632 bottles
Reason for recall
Failed Dissolution Specification
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Ascend Laboratories, LLC
Address
339 Jefferson Rd Ste 101, N/A

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

Codes & Dates

Recall number
D-0169-2023
Event ID
91442
Recall initiation date
January 5, 2023
Center classification date
January 20, 2023
Code info
Lot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.
More code info
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