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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01

Is my product affected?

E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01

  • Brand E-Z-HD

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling E-Z-HD (Barium Sulfate for Oral Suspension), a prescription diagnostic imaging product, due to temperature abuse during handling that violated manufacturing quality standards. The affected product is a 340-gram bottle with NDC 32909-764-01, manufactured by Bracco Diagnostics Inc. Approximately 19 cases were distributed nationwide across the United States.

The recall affects product that may have been shipped during specific date ranges, which McKesson has identified in individual letters sent to affected customers based on their distribution dates. The source does not specify a remedy or corrective action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 19 cases Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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