Granules Pharmaceuticals Inc.: Drug Recall

Recall #D-0187-2025 · 12/18/2024

Class II: Risk

Recall Details

Recall Number
D-0187-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Granules Pharmaceuticals Inc.
Status
Terminated
Date Initiated
12/18/2024
Location
Chantilly, VA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96 Bottles

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Other Recalls by Granules Pharmaceuticals Inc.

View all recalls by Granules Pharmaceuticals Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.