Drug Enforcement D-885-2013

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

Status

Terminated

Classification

Class II

Report Date

August 21, 2013

Termination Date

January 23, 2015

Product Information

Product description
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
Product quantity
29,436 bottles
Reason for recall
Presence of foreign substance: One lot of the product may contain black foreign particles
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Bracco Diagnostics Inc
Address
259 Prospect Plains Rd., Building H

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-885-2013
Event ID
65878
Recall initiation date
June 21, 2013
Center classification date
August 12, 2013
Code info
Lot # 00500512, Exp. 11/15
More code info
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