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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1084-2022 |
| Event ID | 89646 |
| Brand | E-Z-HD |
| Generic Name | BARIUM SULFATE |
| Manufacturer | BARIUM SULFATE |
| Original Package? | 1 |
| Active Substance | BARIUM SULFATE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 19 cases |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 32909-764 |
| Product NUI | N0000180185 N0000010258 |
| Pharma Class (EPC) | Radiographic Contrast Agent [EPC] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 25BB7EKE2E |
| Drug Application Number | NDA208036 |
| 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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