FDA Drug recall D-0609-2018
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary o…
- FDA Drug
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary o… by Bracco Diagnostics, citing failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0609-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-08 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bracco Diagnostics |
| Distribution | US |
Product
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
Reason
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Identifiers
| ndc | 32909-770-01 |
|---|---|
| code_info | Lot # 00538529 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0609-2018%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.