D-0187-2025 Class II Terminated
FDA drug recall D-0187-2025 was initiated by Granules Pharmaceuticals Inc. on Dec 18, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. The recall status is terminated (terminated Jul 1, 2025). Affected quantity: 96 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 15, 2025
- Initiation Date
- Dec 18, 2024
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0187-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026