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.
What this means for you
Illness, injury, or structural failure has been reported. 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 →Related recalls
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