The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0315-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 141 vials of TriMix compounded injections nationwide due to a lack of assurance of sterility.

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 the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 141 vials of TriMix, a compounded medication containing Alprostadil, Phentolamine, and Papaverine. The recall is being conducted because of a lack of assurance of sterility in the products.

The affected products were compounded between May 17, 2016, and November 17, 2016, and were distributed nationwide. The recall includes specific lot codes with expiration dates ranging from May 22, 2016, to December 9, 2016.

Consumers who have purchased 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 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
141

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 (20)

  • 06092016C (07/17/2016)
  • 05022016E (05/22/2016)
  • 06232016D (08/04/2016)
  • 06202016B (07/17/2016)
  • 06152016E (07/17/2016)
  • 06082016E (07/17/2016)
  • 06022016C (07/17/2016)
  • 07282016F (09/08/2016)
  • 07262016G (09/04/2016)
  • 07222016D (09/04/2016)
  • 07192016D (09/01/2016)
  • 07152016F (08/22/2016)
  • 07082016C (08/22/2016)
  • 08292016C (09/29/2016)
  • 08052016C (09/16/2016)
  • 08042016H (09/18/2016)
  • 08022016E (09/16/2016)
  • 09272016C (11/06/2016)
  • 11012016B (12/09/2016)
  • 05192016B (07/03/2016)

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

Same manufacturer · Tri-Coast Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls