FDA recall D-0187-2025

Granules Pharmaceuticals Inc. · Class II · drug

Product

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

Reason for recall

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2024-12-18
Report date
2025-01-15
Termination date
2025-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chantilly, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0187-2025