FDA Drug recall D-885-2013
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactur…
- FDA Drug
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactur… by Bracco Diagnostics, citing presence of foreign substance: One lot of the product may contain black foreign particles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-885-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-21 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bracco Diagnostics |
| Distribution | US |
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
Presence of foreign substance: One lot of the product may contain black foreign particles
Identifiers
| ndc | 0270-0445-35 |
|---|---|
| ndc | 0270-0445-40 |
| code_info | Lot # 00500512, Exp. 11/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-885-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.