Drug Enforcement D-0092-2024

Failed Dissolution Specifications: Out of specification for dissolution.

Status

Ongoing

Classification

Class II

Report Date

November 15, 2023

Termination Date

—

Product Information

Product description
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Product quantity
16,944 bottles
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

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

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

Codes & Dates

Recall number
D-0092-2024
Event ID
93263
Recall initiation date
October 23, 2023
Center classification date
November 7, 2023
Code info
Lot # 17230388, Exp. 01/31/2025
More code info
—