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.
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, 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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