Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Reported: January 15, 2025 Initiated: December 18, 2024 #D-0187-2025
Product Description
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Reason for Recall
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Details
- Recalling Firm
- Granules Pharmaceuticals Inc.
- Units Affected
- 96 Bottles
- Distribution
- Nationwide within the United States
- Location
- Chantilly, VA
Frequently Asked Questions
What product was recalled? ▼
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03. Recalled by Granules Pharmaceuticals Inc.. Units affected: 96 Bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2025. Severity: Moderate. Recall number: D-0187-2025.
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