Health Innovations Pharmacy Recalls Methenamine Capsules Due to Sterility Concerns
Health Innovations Pharmacy is recalling Methenamine/Phenyl Salicylate Capsules due to quality control issues that may affect 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly states that the quality control issues present a risk to sterility, which aligns with the 'Severe' criteria for significant risk or Class II recalls with potential for serious harm.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Methenamine/Phenyl Salicylate Capsules. The recall was initiated because recent inspection observations identified issues with certain quality control procedures. These issues present a risk to the sterility and quality assurance of the product, as stability data does not support the expiry date.
The recall covers all lots of the product. The distribution pattern is listed as NC (North Carolina). No specific number of affected units or reported illnesses is provided in the source text.
Consumers who have this product should contact Health Innovations Pharmacy at (910) 246-5155 for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Methenamine/Phenyl Salicylate Capsule, 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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