Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 13 vials of 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 identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly given the risk of infection associated with non-sterile injectable medications.
Plain-English summary
Tri-Coast Pharmacy is recalling 13 vials of TriMix, a compounded medication containing Alprostadil, Phentolamine, and Papaverine. The recall is being conducted because there is a lack of assurance that the sterile products were properly sterilized during the compounding process.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes affected include 06282016A, 06222016C, 07182016D, 11102016D, and 10202016B. The products were distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the affected vials. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 13
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)
- 06222016C (08/04/2016)
- 07182016D (09/01/2016)
- 11102016D (12/09/2016)
- 10202016B (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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