Health Innovations Pharmacy Recalls Trimix Injection Due to Sterility Concerns
Health Innovations Pharmacy is recalling Trimix #1 (Original) Injection 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable drugs are categorized as Severe (Score 4), particularly when structural or quality defects pose a risk to patient safety.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10 mL). 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 FDA classified this recall as Class II. The source text indicates that the lack of assurance of sterility and stability data does not support the product's expiry. All lots of the product are affected. The distribution pattern is listed as NC (North Carolina).
Consumers who have this product should contact Health Innovations Pharmacy at (910) 246-5155 for instructions on how to return the product or obtain a refund. The pharmacy is located at 295 Pinehurst Ave, Southern Pines, NC 28387.
The recalled product
- Product
- Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10 mL), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Injectable
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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