Tri-Coast Pharmacy Recalls Quad Mix Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Quad Mix compounded drug products because they may not be sterile. The recall covers vials compounded between May and November 2016.
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 risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Tri-Coast Pharmacy is recalling specific lots of Quad Mix, a compounded drug product containing Alprostadil, Phentolamine, Papaverine, and Atropine. The recall is being conducted because the products lack assurance of sterility.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot code is 05242016A, with an expiration date of July 8, 2016. The product was distributed nationwide in 5-vial packages.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for instructions on return or replacement.
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 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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