Drug Enforcement D-0335-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

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Product Information

Product description
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60
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
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Codes & Dates

Recall number
D-0335-2025
Event ID
96474
Recall initiation date
March 13, 2025
Center classification date
April 8, 2025
Code info
Lot # 17240040, exp. date Dec-25
More code info
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