Drug Enforcement D-0345-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

—

Product Information

Product description
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
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-0345-2025
Event ID
96474
Recall initiation date
March 13, 2025
Center classification date
April 8, 2025
Code info
30-Count Bottle Lots: 17241788, exp. date Sep-26 17241821, exp. date Sep-26 17241822, exp. date Sep-26 90-Count Bottle Lot: 17241822, exp. date Sept 26
More code info
—