Product Safety Recalls

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PROPOFOL Recall D-1540-2022

Description: PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

PROPOFOL Recall D-1540-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1540-2022
Event ID90785
BrandPROPOFOL
Generic NamePROPOFOL
ManufacturerPROPOFOL
Original Package?1
Active SubstancePROPOFOL
Drug RouteINTRAVENOUS
DistributionUSA Nationwide
Quantity5,390 vials
Recall ReasonPresence of particulate matter
Drug ClassificationClass I
Drug Code Info20220921
Product NDC0409-4699 0409-6010
Product NUIN0000175975 N0000175681
Pharma Class (PE)General Anesthesia [PE]
Pharma Class (EPC)General Anesthetic [EPC]
Recall Initiation Date20220822
Report Date20220921
Classification Date20220919
Address235 East 42nd Street
New York, NY 10017-5703
United States
Recalling FirmPfizer Inc.
Initial Notification Press Release
Unique Ingredient IdentifierYI7VU623SF
Drug Application NumberANDA077908
Structured Product Labeling (SPL ID)efa079a1-3089-4139-a288-6f25e860bd0e
Structured Product Labeling (SPL Set ID)28d7ba00-f824-4e55-139a-03f509c099db
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