E-Z-Paste Barium Sulfate Esophageal Cream — Class II drug recall D-0609-2018
Terminated recall by Bracco Diagnostics Inc., reported 2018-04-04, distributed nationwide. Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben -
| Recall number | D-0609-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostics Inc., Monroe Township, NJ, United States |
| Recall initiated | 2018-03-08 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK, NZ |
| Quantity | 2,136 tubes |
| Reason classes | potency, specification failure |
| NDC | 32909-0770, 32909-0770-01 |
| Lot numbers | 00538529 |
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 for recall
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
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-0609-2018. 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.