Class III · Low risk
Gastrografin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of foreign substance: One lot of the product may contain black foreign particles
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What 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
Affected NDC
0270-0445-40
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Gastrografin diatrizoate meglumine and diatrizoate sodium NDC 00270-0445 |
DIATRIZOATE MEGLUMINE 660 mg/mL; DIATRIZOATE SODIUM 100 mg/mL | Liquid Oral|rectal |
Bracco Diagnostics Inc | Rx |
- Recalling firm
- Bracco Diagnostics Inc
- NDC code
- 0270-0445-40
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-885-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
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Class II · Moderate risk
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Other recalls by Bracco Diagnostics Inc
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Class II · Moderate risk
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