Health Innovations Pharmacy Recalls Phenylephrine Solution Due to Sterility Concerns
Health Innovations Pharmacy is recalling Phenylephrine 0.5% Solution due to quality control issues that present a risk to sterility and stability.
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, and the source text explicitly states that no illnesses or injuries have been reported, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling all lots of Phenylephrine 0.5% Solution (Bottle). The recall is being conducted because recent inspection observations identified certain quality control procedures that do not support the product's expiry date and present a risk to sterility and quality assurance.
The product was distributed in North Carolina. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of this product.
Consumers who have this product should stop using it and contact Health Innovations Pharmacy at (910) 246-5155 for further instructions.
The recalled product
- Product
- Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Ophthalmic Solution
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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