Health Innovations Pharmacy Recalls Dexamethasone Iontophoresis Solution Due to Sterility Concerns
Health Innovations Pharmacy is recalling Dexamethasone 4 mg/mL Iontophoresis solution because inspection findings raised concerns about 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 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 rubric criteria for a Severe rating involving significant risk factors.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Dexamethasone 4 mg/mL Iontophoresis solution. The recall was initiated due to recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
The recall covers all lots of the product. The distribution pattern is listed as NC, indicating the product was distributed in North Carolina.
Consumers who have this product should contact Health Innovations Pharmacy at (910) 246-5155 for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
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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