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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1086-2022 |
| Event ID | 89646 |
| Brand | GASTROGRAFIN |
| Generic Name | DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM |
| Manufacturer | DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM |
| Original Package? | 1 |
| Active Substance | DIATRIZOATE MEGLUMINE DIATRIZOATE SODIUM |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 1 case |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0270-0445 |
| Drug UPC | 0302700445403 |
| 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 | 3X9MR4N98U V5403H8VG7 |
| Drug Application Number | NDA011245 |
| 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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