The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0319-2017·Announced 2017-01-11

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a risk of harm even without reported injuries.

Plain-English summary

Tri-Coast Pharmacy is recalling 17 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.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes affected include 07112016B, 09222016H, 10252016F, 09232016S, 09072016E, and 11032016F. The products were distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot codes and dates. If the product is found, it should be returned to the pharmacy or the manufacturer for disposal or credit.

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 (5)

  • 09222016H (11/06/2016)
  • 10252016F (12/09/2016)
  • 09232016S (11/06/2016)
  • 09072016E (09/29/2016)
  • 11032016F (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 →

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