US Compounding product recalled over sterility concerns

Recall date

September 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

US Compounding Inc recalls Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose…

Recall number

D-0288-2016

FDA classification

Class II

Brand / firm

US Compounding Inc

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05