Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling TriMix injections because the products may not be sterile. The recall covers vials 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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity 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 products lack assurance of sterility. The affected products are 1 mL vials with a concentration of 20mcg/0.5mg/30mg/mL.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes with expiration dates are 06012016E (07/16/2016), 09272016B (11/06/2016), 10032016G (11/14/2016), and 11012016D (12/09/2016). 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 the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 8
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)
- 09272016B (11/06/2016)
- 10032016G (11/14/2016)
- 11012016D (12/09/2016).
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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