Drug Enforcement D-0095-2024

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

November 15, 2023

Termination Date

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Product Information

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
Product quantity
5,856 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA 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-0095-2024
Event ID
93219
Recall initiation date
October 20, 2023
Center classification date
November 8, 2023
Code info
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
More code info
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