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

Recall Number: D-0187-2025

Firm: Granules Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20250115

Initiation Date: 20241218

Termination Date: 20250701

Reason for Recall

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

Product Description

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