Product Safety Recalls

Product Recall Tracker

APREPITANT Recall D-1027-2022

Description: Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG: Sandoz Pharma, NDC 0781-2321-06

APREPITANT Recall D-1027-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1027-2022
Event ID89646
BrandAPREPITANT
Generic NameAPREPITANT
ManufacturerAPREPITANT
Original Package?1
Active SubstanceAPREPITANT
Drug RouteORAL
DistributionUSA nationwide.
Quantity29 boxes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0781-2321 0781-2322 0781-4063
Product NUIN0000010262 N0000175786 N0000182141
Pharma Class (EPC)Substance P/Neurokinin-1 Receptor Antagonist [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 Identifier1NF15YR6UY
Drug Application NumberANDA090999
Structured Product Labeling (SPL ID)fabed213-6059-4862-b09a-38718218a303
Structured Product Labeling (SPL Set ID)f58b8944-93ee-4be1-a238-cc0061ddd93a
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