The Recall Desk
SevereFDA (Drugs)·D-941-2013·Announced 2013-09-18

FDA Recalls Bi-Mix Phentolamine/Papaverine Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Bi-Mix Phentolamine/Papaverine injectable products because FDA inspections raised concerns about quality control and sterility assurance.

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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failure in injectables) are categorized as Severe (Score 4), particularly given the structural nature of the quality control defect impacting sterility assurance.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Bi-Mix Phentolamine/Papaverine 0.5 mg/30 mg/ml and 1 mg/30 mg/ml injectable products. These sterile, prescription-only medications are intended for intravenous and subcutaneous use only. The products were compounded by Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions, located in Southfield, Michigan.

The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings identified concerns associated with quality control procedures that impacted the assurance of sterility for these compounded products. The recall covers all presentations of the affected products.

Patients who have received these injections should contact their healthcare provider for guidance. The FDA classifies this as a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Manufacturer
Beacon Hill Medical Pharmacy, P.C.
Category
Drug — Compounded Injectable
Hazard

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)

  • 07232013@23 and 04232013@27

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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.

See all 86 products in this recall →

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Same hazard · sterility failure

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