Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals ...
FDA Recall #D-0187-2025 — Class II — December 18, 2024
Product Description
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.
Recalling Firm
Granules Pharmaceuticals Inc. — Chantilly, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
96 Bottles
Distribution
Nationwide within the United States
Code Information
Lot#: GPC240763B, Exp. Date 6/17/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated