Health Innovations Pharmacy Recalls Keto-Gabap-Ketamine Cream Due to Sterility Concerns
Health Innovations Pharmacy is recalling Keto 10%-Gabap 10%-Ketamine 2% Cream 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 involves a risk to sterility and quality assurance without reported illnesses or injuries, 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 Keto 10%-Gabap 10%-Ketamine 2% Cream. The recall was initiated following recent inspection observations associated with certain quality control procedures. These observations present a risk to sterility and quality assurance, specifically noting a lack of assurance of sterility and that stability data does not support the expiry date.
The recall covers all lots of the product. The distribution pattern is listed as NC, indicating the product was distributed in North Carolina. The product was manufactured by Health Innovations Pharmacy, Inc., located at 295 Pinehurst Ave, Southern Pines, NC 28387.
Consumers who have this product should stop using it and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Keto 10%-Gabap 10%-Ketamine 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Topical Cream
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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