D-0187-2025 Class II Terminated

Recalled by Granules Pharmaceuticals Inc. — Chantilly, VA

Recall Details

Product Type
Drugs
Report Date
January 15, 2025
Initiation Date
December 18, 2024
Termination Date
July 1, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96 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

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot#: GPC240763B, Exp. Date 6/17/2026