CLASS II Drug recall · Reported 21 Aug 2013 · FDA Enforcement Report
Gastrografin (Diatrizoate Meglumine recalled by Bracco Diagnostics
Bracco Diagnostics is recalling Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37%, distributed nationwide in the US. The recall was initiated on 21 Jun 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-885-2013
- FDA event ID
- 65878
- Recalling firm
- Bracco Diagnostics, Monroe Township, NJ
- Brand
- Gastrografin
- Manufacturer
- Bracco Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2013
- FDA classified
- 12 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 21 Jun 2013 | Recall initiated by company | |
| 12 Aug 2013 | Classified by FDA | +52 days |
| 21 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance: One lot of the product may contain black foreign particles
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign substance: One lot of the product may contain black foreign particles
Which lots are affected?
Lot # 00500512, Exp. 11/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bracco Diagnostics
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube recalledE-z-paste | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS III | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w) recalled | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS III | Tagitol V Barium Sulfate Suspension (40% w/v recalled | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS II | Cardiogen-82 (Rubidium Rb 82 Generator), 140 millicurie recalledCardiogen-82 | Bracco Diagnostics | Processing Deviation | Nationwide |
| Drug | CLASS II | Multihance Multipack (gadobenate dimeglumine) injection recalledMultihance | Bracco Diagnostics | Sterility | Nationwide |
Other Diatrizoate Meglumine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gastrografin (Diatrizoate Meglumine recalledGastrografin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MD-Gastroview (Diatrizoate Meglumine recalled by MallinckrodtMd Gastroview | Mallinckrodt | Other | MO |