Drug Enforcement D-0643-2024

Failed Dissolution Specifications: below specification results

Status

Ongoing

Classification

Class II

Report Date

September 4, 2024

Termination Date

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Product Information

Product description
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Product quantity
2404 bottles
Reason for recall
Failed Dissolution Specifications: below specification results
Recall initiation reason
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Initial firm notification
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Distribution pattern
Nationwide USA

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0643-2024
Event ID
95075
Recall initiation date
July 31, 2024
Center classification date
August 23, 2024
Code info
Lot#: 17240105, Exp 12/31/2025
More code info
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