Tri-Coast Pharmacy Recalls BiMix Phentolamine/Papaverine Due to Sterility Concerns
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine vials 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 severity score under the rubric for drug recalls.
Plain-English summary
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML) vials. The recall is due to a lack of assurance of sterility for the compounded products.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. One known lot code is 07222016H, with an expiration date of September 5, 2016. The source indicates that 5 vials are involved in the recall quantity.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- 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.
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