Colchicine Capsule
FDA Recall NDC 70010-001
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Colchicine (NDC 70010-001). A significant event, classified as Class II, was initiated on Dec 18, 2024 by Granules Pharmaceutical Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Dec 18, 2024
Jan 15, 2025
96 Bottles
Recall Profile & Regulatory Data
Event ID
96026
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jul 01, 2025
Product Description
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Batch or Lot Expiration Information
Lot# : GPC240763B, Exp. Date 6/17/2026
Affected Packages Involved in this Recall
70010-001-01Product
70010-001-10Product
70010-001-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
