Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0095-2024

D-0095-2024 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
November 15, 2023
Initiation Date
October 20, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,856 bottles

Product Description

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

USA nationwide

Code Information

Lot #: 17220063, Exp 12/2023; 17220396, 17220397, Exp 01/2024; 17220965, Exp 04/2024; 17221187, 17221523, Exp 07/2024; 17221793, 17221794, 17221801, Exp 08/2024

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  • D-0662-2025 Class II — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: (September 17, 2025)
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  • D-0577-2025 Class II — Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-16 (August 7, 2025)
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  • D-0578-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl (August 7, 2025)
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