FDA-Drug2013-01-09Class II

Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
8919 vials
Manufactured in
697 Waverly St, N/A, Framingham, MA, United States
Products
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-122-2013

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