Drug Enforcement D-0331-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

—

Product Information

Product description
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01
Product quantity
N/A
Reason for recall
CGMP Deviations
Recall initiation reason
—
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-0331-2025
Event ID
96474
Recall initiation date
March 13, 2025
Center classification date
April 8, 2025
Code info
Lot # 17232361, exp. date Nov-25 17232367, exp. date Nov-25 17240037, exp. date Dec-25 17240038, exp. date Dec-25
More code info
—