Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bottles, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0445-35
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP) distributed nationwide in the United States. The recall involves one case containing twenty-four 30 mL single dose bottles. The product is being recalled due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during storage or handling.
The source does not specify what action affected consumers should take in response to this recall. McKesson Medical-Surgical has noted that it cannot identify which specific lot number was received by individual customers, but indicates that recall letters to customers will include the distribution date and the timeframe when affected product may have been shipped to them.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 1 case 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.