FDAHealthDecember 18, 2024
Granules Pharmaceuticals Inc. — Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
⚠️ Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 18, 2024
Nationwide within the United States
What's affected?
- Product
- Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
- Brand
- COLCHICINE
- UPC
- 0370010001039
- Lot code
- GPC240763B
Additional details
Lot#: GPC240763B, Exp. Date 6/17/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 96 Bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.