FDA-Drug2015-11-25Class II

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

US Compounding Inc
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.

Sold states
Nationwide
Affected count
8,218 vials
Manufactured in
1270 Don's Lane, N/A, Conway, AR, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0272-2016

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