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DIATRIZOATE MEGLUMINE Recall D-1086-2022

Description: 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

DIATRIZOATE MEGLUMINE Recall D-1086-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1086-2022
Event ID89646
BrandGASTROGRAFIN
Generic NameDIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
ManufacturerDIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Original Package?1
Active SubstanceDIATRIZOATE MEGLUMINE DIATRIZOATE SODIUM
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 case
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0270-0445
Drug UPC0302700445403
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier3X9MR4N98U V5403H8VG7
Drug Application NumberNDA011245
Structured Product Labeling (SPL ID)7c17ff73-033f-4c13-b31d-3f84a9f88768
Structured Product Labeling (SPL Set ID)8c2340e4-2b42-45dc-8fac-9960e8172547
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