Tri-Coast Pharmacy Recalls Quad Mix Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Quad Mix compounded injections 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, which corresponds to a 'Severe' rating under the rubric for significant health risks such as sterility failures in injectable medications.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling specific lots of Quad Mix, a compounded sterile injection 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 affected products.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot codes involved are 10262016H (expiration date 12/09/2016) and 11032016C (expiration date 12/09/2016). Each unit consists of 10 vials of 1 mL each.
These products were distributed nationwide. Patients who have received this medication should contact their healthcare provider for guidance on next steps and potential alternatives.
The recalled product
- Product
- Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/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)
- 11032016C (12/09/2016).
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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