Drug Enforcement D-0085-2024

Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class III

Report Date

November 8, 2023

Termination Date

August 16, 2024

Product Information

Product description
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Product quantity
480 100-count bottles
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr, N/A

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

Codes & Dates

Recall number
D-0085-2024
Event ID
93252
Recall initiation date
October 20, 2023
Center classification date
November 2, 2023
Code info
Lot# 17212352, Exp 11/31/2023
More code info
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