Gastrografin — Class II drug recall D-885-2013
Terminated recall by Bracco Diagnostics Inc, reported 2013-08-21, distributed nationwide. Presence of foreign substance: One lot of the product may contain black foreign particles
| Recall number | D-885-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostics Inc, Monroe Township, NJ, United States |
| Recall initiated | 2013-06-21 |
| Classified | 2013-08-12 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2015-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 29,436 bottles |
| NDC | 00270-0445, 00270-0445-35, 00270-0445-40 |
| Lot numbers | 00500512, 11/15 |
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
Reason for recall
Presence of foreign substance: One lot of the product may contain black foreign particles
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-885-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.