Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1119-2022
Event ID89646
BrandINTRALIPID
Generic NameI.V. FAT EMULSION
ManufacturerI.V. FAT EMULSION
Original Package?1
Active SubstanceSOYBEAN OIL
Drug RouteINTRAVENOUS
DistributionUSA nationwide.
Quantity5 cases
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0338-0519
Product NUIN0000191261 M0012553
Pharma Class (EPC)Lipid Emulsion [EPC]
Pharma Class (CS)Lipids [CS]
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 Identifier241ATL177A
Drug Application NumberNDA018449
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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