The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0281-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Quad Mix Compounded Drug Due to Sterility Concerns

Tri-Coast Pharmacy is recalling Quad Mix compounded drug vials 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, and the hazard 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 Quad Mix, a compounded drug 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 products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot code is 06162016B, with an expiration date of July 17, 2016. The product was distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling pharmacy for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Drug
Hazard
Affected units
2

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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