Product Safety Recalls

Product Recall Tracker

PROPOFOL Recall D-1116-2022

Description: Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29

PROPOFOL Recall D-1116-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1116-2022
Event ID89646
BrandDIPRIVAN
Generic NamePROPOFOL
ManufacturerPROPOFOL
Original Package?1
Active SubstancePROPOFOL
Drug RouteINTRAVENOUS
DistributionUSA nationwide.
Quantity46 cartons
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC63323-269
Product NUIN0000175975 N0000175681
Drug UPC0363323269227
Pharma Class (PE)General Anesthesia [PE]
Pharma Class (EPC)General Anesthetic [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 IdentifierYI7VU623SF
Drug Application NumberNDA019627
Structured Product Labeling (SPL ID)824826e9-2ac5-44af-a014-8e33c30d5598
Structured Product Labeling (SPL Set ID)ee0c3437-614d-4631-a061-257f5f60c70b
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