Recalls / Class II
Class IID-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
- Brand name
- Gastrografin
- Generic name
- Diatrizoate Meglumine And Diatrizoate Sodium
- Active ingredients
- Diatrizoate Meglumine, Diatrizoate Sodium
- Route
- Oral, Rectal
- NDC
- 0270-0445
- FDA application
- NDA011245
- Affected lot / code info
- Lot # 00500512, Exp. 11/15
Why it was recalled
Presence of foreign substance: One lot of the product may contain black foreign particles
Recalling firm
- Firm
- Bracco Diagnostics Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Rd., Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 29,436 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-06-21
- FDA classified
- 2013-08-12
- Posted by FDA
- 2013-08-21
- Terminated
- 2015-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-885-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.