Drug recall D-0187-2025

Class II Terminated reported Jan 15, 2025

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.

Lots and codes

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

Recall details

Recalling firm
Granules Pharmaceuticals Inc., Chantilly, VA
Quantity
96 Bottles
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
December 18, 2024
Terminated
July 1, 2025

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