Health Innovations Pharmacy Recalls Colchicine Capsules Due to Sterility Concerns
Health Innovations Pharmacy is recalling Colchicine 0.6 mg capsules because inspection observations indicate a lack of assurance regarding sterility and stability data.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is described as a risk to sterility and quality assurance based on inspection observations, fitting the criteria for a moderate severity recall where the risk is present but not yet linked to reported harm.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Colchicine 0.6 mg capsules. The recall was initiated following recent inspection observations associated with certain quality control procedures. These observations present a risk to sterility and quality assurance, specifically regarding the lack of assurance of sterility and stability data supporting the product's expiry.
The recall applies to all lots of the product. The distribution pattern is listed as NC (North Carolina). The source text does not specify the exact number of units affected or specific distribution locations beyond the state code.
Consumers who have purchased these capsules should contact Health Innovations Pharmacy at (910) 246-5155 for further instructions. The source text does not provide specific consumer action steps beyond the general recall context.
The recalled product
- Product
- Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 65 recalled by Health Innovations Pharmacy, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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