Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling TriMix compounded injections because the agency could not ensure the products were sterile.
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 source text explicitly states the agency classification is Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe).
Plain-English summary
Tri-Coast Pharmacy is recalling TriMix, a compounded medication containing alprostadil, phentolamine, and papaverine. The recall is being conducted because the U.S. Food and Drug Administration (FDA) determined there was a lack of assurance of sterility for the affected products.
The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. The source text identifies a known lot code with an expiration date of July 17, 2016. The affected products were distributed nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by Tri-Coast Pharmacy 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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