The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0286-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Quad Mix Compounded Sterile Drug Vials

Tri-Coast Pharmacy is recalling 17 vials of Quad Mix compounded sterile drug due to a lack of assurance of sterility. The products were distributed nationwide.

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 a drug product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Tri-Coast Pharmacy is recalling 17 vials of Quad Mix, a compounded sterile drug containing Alprostadil, Phentolamine, Papaverine, and Atropine. The recall is being conducted due to a lack of assurance of sterility in the products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes include 07252016E, 09142016A, 07192016E, and 07052016B. The affected products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Drug
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)

  • 09142016A (09/29/2016)
  • 07192016E (09/01/2016)
  • 07052016B (08/04/2016).

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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