Recalls / Class II
Class IID-0187-2025
Product
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
- Brand name
- Colchicine
- Generic name
- Colchicine
- Active ingredient
- Colchicine
- Route
- Oral
- NDC
- 70010-001
- FDA application
- ANDA210757
- Affected lot / code info
- Lot#: GPC240763B, Exp. Date 6/17/2026
Why it was recalled
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Recalling firm
- Firm
- Granules Pharmaceuticals Inc.
- Manufacturer
- Granules Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3701 Concorde Pkwy, Chantilly, Virginia 20151-1126
Distribution
- Quantity
- 96 Bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-12-18
- FDA classified
- 2025-01-07
- Posted by FDA
- 2025-01-15
- Terminated
- 2025-07-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0187-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.