FDA recall D-0095-2024

Product

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

USA nationwide

Key facts

Status

Ongoing

Initiation date

2023-10-20

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2024