SOYBEAN OIL Recall D-1119-2022
Description: Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-09
SOYBEAN OIL Recall D-1119-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1119-2022 |
| Event ID | 89646 |
| Brand | INTRALIPID |
| Generic Name | I.V. FAT EMULSION |
| Manufacturer | I.V. FAT EMULSION |
| Original Package? | 1 |
| Active Substance | SOYBEAN OIL |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | 5 cases |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0338-0519 |
| Product NUI | N0000191261 M0012553 |
| Pharma Class (EPC) | Lipid Emulsion [EPC] |
| Pharma Class (CS) | Lipids [CS] |
| 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 | 241ATL177A |
| Drug Application Number | NDA018449 |
| Structured Product Labeling (SPL ID) | 7f10161b-9ece-3f03-e053-2991aa0adcd4 |
| Structured Product Labeling (SPL Set ID) | a69c82da-15ba-4d4d-8d7f-871dc3981eb8 |
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