FDAClass IIJanuary 15, 2025

Colchicine Capsules 0.6 mg recall: Failed Dissolution

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

Why was Colchicine Capsules 0.6 mg recalled?

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: GPC240763B, Exp. Date 6/17/2026

Product
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Recalling firm
Granules Pharmaceuticals Inc.
Quantity
96 Bottles
Distribution
Nationwide within the United States
Recall date
January 15, 2025
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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