Recall D-0187-2025

US Class II Terminated · initiated 2024-12-18

Recalling firm

Granules Pharmaceuticals Inc., VA

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.

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