US Compounding Inc recalls Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compoun
Recalled November 25, 2015 · FDA recall D-0272-2016 · US Compounding
Hazard
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. · FDA Class II
Units
8,218 vials
Sold at
Nationwide
Description
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.
Product
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
Manufacturer(s)
US Compounding Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →