Monroe Township, NJ, United States
Bracco Diagnostics Inc. recalls
1 recall recorded since 2018, most recently on 8 March 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 8 March 2018
- Terminated
- 1 March 2019
- Reason
- Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
- Distribution
- Product was distributed throughout the United States, Hong Kong and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.