Drug product
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
D-0187-2025
Product summary
- Event
- Event 96026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 Bottles
- Official record key
drug-enforcement:D-0187-2025
Official wording
Reason: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Code information: Lot#: GPC240763B, Exp. Date 6/17/2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification