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
Reported: August 21, 2013 Initiated: June 21, 2013 #D-885-2013
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
Reason for Recall
Presence of foreign substance: One lot of the product may contain black foreign particles
Details
- Recalling Firm
- Bracco Diagnostics Inc
- Units Affected
- 29,436 bottles
- Distribution
- Nationwide
- Location
- Monroe Township, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bracco Diagnostics Inc. Units affected: 29,436 bottles.
Why was this product recalled? ▼
Presence of foreign substance: One lot of the product may contain black foreign particles
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2013. Severity: Moderate. Recall number: D-885-2013.
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