Health Innovations Pharmacy Recalls Naltrexone Capsules Due to Sterility Concerns
Health Innovations Pharmacy is recalling Naltrexone 4.5 mg capsules because inspection findings indicate a lack of assurance regarding 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 is classified as FDA Class II, and the hazard involves a risk to sterility and quality assurance without reported illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Naltrexone 4.5 mg capsules. The recall was initiated following recent inspection observations related to certain quality control procedures. These observations present a risk to sterility and quality assurance, specifically regarding the lack of assurance of sterility and stability data supporting the product's expiry.
The recall covers all lots of the product. The distribution pattern is listed as NC, indicating the product was distributed in North Carolina. The source text does not specify the exact number of units affected or the specific dates of distribution.
Consumers who have purchased Naltrexone 4.5 mg capsules from Health Innovations Pharmacy should stop using the product and contact the pharmacy for further instructions or a refund. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Naltrexone 4.5 mg Caps, 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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