Drug Enforcement D-0187-2025

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

Status

Terminated

Classification

Class II

Report Date

January 15, 2025

Termination Date

July 1, 2025

Product Information

Product description
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Product quantity
96 Bottles
Reason for recall
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Granules Pharmaceuticals Inc.
Address
3701 Concorde Pkwy

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0187-2025
Event ID
96026
Recall initiation date
December 18, 2024
Center classification date
January 7, 2025
Code info
Lot#: GPC240763B, Exp. Date 6/17/2026
More code info
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