Coconut Oil Suppository Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Coconut Oil 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 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risks to sterility and quality assurance.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Coconut Oil Suppositories. The recall is due to recent inspection observations regarding quality control procedures that present a risk to sterility and quality assurance.
The source text indicates that a lack of assurance of sterility and stability data does not support the product's expiry. This suggests potential issues with the product's safety and shelf life.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Coconut Oil Suppository, 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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