Drug & medication recalls Moderate risk

Granules Pharmaceuticals Inc. recalls Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 201…

Recall date
December 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0187-2025
FDA classification
Class II
Brand / firm
Granules Pharmaceuticals Inc.
Sold / distributed
Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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