Drug 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
D-885-2013
Product summary
- Event
- Event 65878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,436 bottles
- Official record key
drug-enforcement:D-885-2013
Official wording
Reason: Presence of foreign substance: One lot of the product may contain black foreign particles
Code information: Lot # 00500512, Exp. 11/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance