Tri-Coast Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the products 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 an injectable product, which poses a significant risk of serious injury or death if the product is contaminated.
Plain-English summary
Tri-Coast Pharmacy is recalling specific lots of Quad Mix, a compounded medication containing alprostadil, phentolamine, papaverine, and atropine. The recall is being issued because the products lack assurance of sterility. The affected products are 1 mL vials with a concentration of 10mcg/2mg/30mg/200mg/ml.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. One known lot code is 08102016F, which has an expiration date of September 18, 2016. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or healthcare provider for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- 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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