Drug recall D-885-2013

Class II Terminated reported Aug 21, 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

Lots and codes

Lot # 00500512, Exp. 11/15

Recall details

Recalling firm
Bracco Diagnostics Inc, Monroe Township, NJ
Quantity
29,436 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 21, 2013
Terminated
January 23, 2015

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