Tri-Coast Pharmacy Recalls BiMix Phentolamine/Papaverine Due to Sterility Concerns
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine vials because there is a lack of assurance of sterility. The recall covers products 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a drug product, which poses a significant risk of infection or serious injury.
Plain-English summary
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML) vials. The recall is due to a lack of assurance of sterility in the compounded products.
The recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. A known lot code is 09302016D with an expiration date of 11/14/2016. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Affected units
- 2
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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