Tri-Coast Pharmacy Recalls Quad Mix Sterile Compounded Drug
Tri-Coast Pharmacy is recalling Quad Mix sterile compounded drug vials 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 a sterile compounded drug, which poses a significant risk of serious injury or death from infection.
Plain-English summary
Tri-Coast Pharmacy is recalling 5 vials of Quad Mix, a sterile compounded drug containing Alprostadil, Phentolamine, Papaverine, and Atropine. The recall is being conducted because of a lack of assurance of sterility in the product.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot code is 07222016B, with an expiration date of September 1, 2016. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Sterile Drug
- Hazard
- Affected units
- 5
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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