Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 2015
Summary
The FDA issued a Class II for Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules by Granules Pharmaceuticals Inc.. Reason: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles..
Details
Source
Drug Recall
External ID
D-0187-2025
Action Date
2025-01-15
Status
Terminated
Category
drug
Product Description
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Lot/Code Info: Lot#: GPC240763B, Exp. Date 6/17/2026
Quantity Affected: 96 Bottles
Reason for Recall
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-18
Company
Chantilly, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Granules Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Granules Pharmaceuticals Inc. have FDA actions?
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0187-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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