Product Safety Recalls

Product Recall Tracker

PROPOFOL Recall D-1078-2022

Description: Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95

PROPOFOL Recall D-1078-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1078-2022
Event ID89646
Generic NamePROPOFOL
Original Package?1
Active SubstancePROPOFOL
DistributionUSA nationwide.
Quantity564 cartons/25 vials each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0591-2136
Product NUIN0000175975 N0000175681
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 NumberANDA205307
Structured Product Labeling (SPL ID)08798d87-7c60-429d-bf0b-fcc6f93fddaa
Structured Product Labeling (SPL Set ID)6f8bebf9-d87b-469a-911a-21135ba841ae
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