Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 17 vials of TriMix injection 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports.
Plain-English summary
Tri-Coast Pharmacy is recalling 17 vials of TriMix, a compounded medication containing alprostadil, phentolamine, and papaverine. The recall was initiated due to a lack of assurance of sterility for the affected products.
The recall includes all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. Specific lot codes identified in the recall are 05312016D, 08162016F, 08312016C, and 08032016E. The products were distributed nationwide.
Consumers who possess these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 17
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 (3)
- 08162016F (09/18/2016)
- 08312016C (09/29/2016)
- 08032016E (09/16/2016).
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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