FDA recall D-885-2013

Product

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40

Reason for recall

Presence of foreign substance: One lot of the product may contain black foreign particles

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-06-21

Report date

2013-08-21

Termination date

2015-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-885-2013