Tri-Coast Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Quad Mix injection vials because the FDA cannot assure the products are sterile. The recall covers vials compounded between May and November 2016.
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 rubric mandates a score of 4 for FDA Class II recalls involving hospitalization reports or significant injury; while the source does not explicitly list hospitalizations, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious harm (sepsis/infection) that aligns with the 'Severe' criteria for structural/sterility defects in medical products.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling specific vials of Quad Mix, a compounded sterile product containing Alprostadil, Phentolamine, Papaverine, and Atropine. The recall is being conducted because the FDA cannot assure the sterility of the affected products.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The source text identifies two known lot codes with expiration dates: 06072016F (expiring July 17, 2016) and 08112016C (expiring September 18, 2016). The affected products were distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the recalled products. The FDA classifies this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 08112016C (09/18/2016).
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.
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