Propofol Injectable Emulsion (Hospira) – Particulate Matter (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
Brand
Hospira Inc.
Lot Codes / Batch Numbers
Lot #: 24-461-DJ*, Exp 12/14, 26-543-DJ*, Exp 02/15, 27-555-DJ*, 27-559-DJ*, Exp 03/15, *lot number may be followed by 01
Products Sold
Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01
Hospira Inc. is recalling Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patien due to Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample insp. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026