Health Innovations Pharmacy Recalls Acetylcysteine 10% Opth Solution
Health Innovations Pharmacy is recalling Acetylcysteine 10% Opth Solution due to lack of assurance of 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk to sterility and quality assurance for a drug product, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Acetylcysteine 10% Opth Solution. The recall is being conducted because of recent inspection observations associated with certain quality control procedures. These observations present a risk to sterility and quality assurance, and stability data does not support the product's expiry.
The recall covers 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 recalled or the specific dates of distribution.
Consumers who have this product should stop using it and contact the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Acetylcysteine 10% Opth Solution, 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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