Gastrografin Prescription Contrast Agent Recalled for Temperature Deviations
McKesson Medical-Surgical is recalling Gastrografin, a prescription diagnostic contrast agent, due to temperature abuse during manufacturing and distribution. The FDA classified this as a Class II recall.
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 drug recall involving manufacturing deviations (temperature abuse) of a prescription pharmaceutical. While no illnesses or injuries are explicitly reported, temperature abuse of a diagnostic contrast agent represents a potential risk to patient safety and efficacy of medical procedures.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Gastrografin (diatrizoate meglumine and diatrizoate sodium solution USP), a prescription diagnostic contrast agent. The affected product is packaged in twenty-four 30 mL single-dose bottles (NDC 0270-0445-35) and was manufactured by Bracco Diagnostics Inc.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse of the product.
The affected product was distributed nationwide throughout the United States. Because McKesson Medical-Surgical could not identify specific lot numbers for individual customers, each customer notification letter includes the distribution date and the dates the product may have been shipped.
The recalled product
- Product
- GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
- Brand
- GASTROGRAFIN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Diagnostic Contrast Agent
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0302700445403
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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