Drug Enforcement D-0348-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

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Product Information

Product description
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Product quantity
N/A
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

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-0348-2025
Event ID
96474
Recall initiation date
March 13, 2025
Center classification date
April 8, 2025
Code info
Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon
More code info
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