Recalls / Class II
Class IID-0609-2018
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
- Brand name
- E-z-paste
- Generic name
- Barium Sulfate
- Active ingredient
- Barium Sulfate
- Route
- Oral
- NDC
- 32909-770
- Affected lot / code info
- Lot # 00538529
Why it was recalled
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Recalling firm
- Firm
- Bracco Diagnostics Inc.
- Manufacturer
- E-Z-EM Canada Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Rd Bldg H, Monroe Township, New Jersey 08831-3820
Distribution
- Quantity
- 2,136 tubes
- Distribution pattern
- Product was distributed throughout the United States, Hong Kong and New Zealand.
Timeline
- Recall initiated
- 2018-03-08
- FDA classified
- 2018-03-29
- Posted by FDA
- 2018-04-04
- Terminated
- 2019-03-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0609-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.