Health Innovations Pharmacy Recalls Nitroglycerin Cream Due to Sterility Concerns
Health Innovations Pharmacy is recalling Nitroglycerin 0.2% Compounded 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 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality control risks like sterility assurance.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Nitroglycerin 0.2% Compounded Cream. The recall was initiated due to recent inspection observations associated with 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. Distribution was limited to 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 at (910) 246-5155 for further instructions.
The recalled product
- Product
- Nitroglycerin 0.2% Compd Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Topical
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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