Spironolactone Suspension Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Spironolactone 5 mg/mL Suspension due to quality control issues affecting 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-of-harm product (sterility and stability issues) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Spironolactone 5 mg/mL Suspension. 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 assigned expiry date.
The recall covers all lots of the product. Distribution was limited to 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 their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Spironolactone 5 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Pharmaceutical
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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