Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 25 vials of TriMix injection because the products lack assurance of sterility. The recall covers products compounded between May and November 2016.
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 and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling 25 vials of TriMix, a compounded medication containing Alprostadil, Phentolamine, and Papaverine. The recall was initiated because the products lack assurance of sterility, which is a critical quality attribute for injectable medications.
The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. Specific lot codes affected include 07152016E, 08012016G, 09162016B, 11032016B, and 10112016C. The products were distributed nationwide.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 25
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 (4)
- 08012016G (09/08/2016)
- 09162016B (09/29/2016)
- 11032016B (12/09/2016)
- 10112016C (11/24/2016).
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.
See all 80 products in this recall →Related recalls
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