FDA-Drug2025-01-15Class II

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

Granules Pharmaceuticals Inc.
Hazard

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

Sold states
Nationwide within the United States
Affected count
96 Bottles
Manufactured in
3701 Concorde Pkwy, Chantilly, VA, United States
Products
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

Official notice

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

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