Nystatin Suppositories Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Nystatin 50,000 Units Suppositories due to quality control issues affecting 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 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 is classified as FDA Class II. The hazard involves a risk to sterility and quality assurance for a drug product, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Nystatin 50,000 Units Suppositories. The recall was initiated because recent inspection observations identified deficiencies in certain quality control procedures. These deficiencies present a risk to the sterility and quality assurance of the product, as stability data does not support the stated expiry.
The recall includes all lots of the product. The distribution pattern is listed as North Carolina (NC). The source text does not specify the exact number of units affected or the specific dates of distribution.
Consumers who have this product should stop using it and contact Health Innovations Pharmacy at (910) 246-5155 or visit 295 Pinehurst Ave, Southern Pines, NC 28387 for further instructions.
The recalled product
- Product
- Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Antifungal
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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