FDA Class II Recall: E-Z-HD Barium Sulfate Oral Suspension Due to Temperature Abuse
McKesson is recalling E-Z-HD (Barium Sulfate for Oral Suspension) due to temperature deviations during manufacturing. Healthcare providers should stop using the recalled product and contact the manufacturer for lot identification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall, indicating a serious manufacturing process deviation. The source text does not report any illnesses, injuries, or deaths. Per the rubric, manufacturing deviations without confirmed harm are classified as High severity.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling E-Z-HD (Barium Sulfate for Oral Suspension), a prescription radiographic contrast agent used in diagnostic imaging procedures. The recalled product is supplied in 340-gram bottles with NDC 32909-764-01, manufactured by Bracco Diagnostics Inc. Nineteen cases were distributed nationwide to healthcare facilities.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process. The company distributed notification letters to affected customers identifying the applicable distribution dates.
Healthcare providers who received this product should cease use of the recalled product. Patients who may have undergone imaging procedures using this product should consult their healthcare provider. Specific lot numbers cannot be identified by McKesson without the distribution date referenced in the notification letter.
The recalled product
- Product
- E-Z-HD (BARIUM SULFATE)
- Brand
- E-Z-HD
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- manufacturing-deviation
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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