Product Safety Recalls

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BARIUM SULFATE Recall D-1084-2022

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

BARIUM SULFATE Recall D-1084-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1084-2022
Event ID89646
BrandE-Z-HD
Generic NameBARIUM SULFATE
ManufacturerBARIUM SULFATE
Original Package?1
Active SubstanceBARIUM SULFATE
Drug RouteORAL
DistributionUSA nationwide.
Quantity19 cases
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC32909-764
Product NUIN0000180185 N0000010258
Pharma Class (EPC)Radiographic Contrast Agent [EPC]
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 Identifier25BB7EKE2E
Drug Application NumberNDA208036
Structured Product Labeling (SPL ID)b64a3b4e-f3ea-d323-d25e-826ca8af5f78
Structured Product Labeling (SPL Set ID)a4330804-7179-472a-91cb-84bbd5079bb8
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