The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0282-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Quad Mix Due to Sterility Concerns

Tri-Coast Pharmacy is recalling Quad Mix compounded injections 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 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, which corresponds to a 'Severe' rating under the rubric for significant health risks such as sterility failures in injectable medications.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling specific lots of Quad Mix, a compounded sterile injection containing Alprostadil, Phentolamine, Papaverine, and Atropine. The recall is being conducted because the U.S. Food and Drug Administration (FDA) determined there was a lack of assurance of sterility for the affected products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot codes involved are 10262016H (expiration date 12/09/2016) and 11032016C (expiration date 12/09/2016). Each unit consists of 10 vials of 1 mL each.

These products were distributed nationwide. Patients who have received this medication should contact their healthcare provider for guidance on next steps and potential alternatives.

The recalled product

Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Injection
Hazard
Affected units
10

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 (1)

  • 11032016C (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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