The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0318-2017·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 cannot assure the product's 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 assurance of sterility 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 17 vials of TriMix, a compounded sterile product containing Alprostadil, Phentolamine, and Papaverine. The recall was initiated because the company cannot assure the sterility of the affected products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes identified in the recall include 07282016G, 07082016E, and 07142016D. The products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the pharmacy for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
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 (2)

  • 07082016E (08/22/2016)
  • 07142016D (08/22/2016).

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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