Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II precautionary recall without reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing process deviation with no evidence of actual product failure or adverse events in clinical use.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Propofol Injectable Emulsion, USP (10 mg/mL) in 50 mL and 100 mL vials distributed nationwide. The recall affects approximately 31 cartons due to cGMP deviations involving temperature abuse during the manufacturing process.
Temperature abuse during manufacturing may compromise the quality and integrity of the injectable emulsion. Propofol is used as an intravenous anesthetic agent in medical settings including operating rooms and intensive care units.
No illnesses or injuries have been reported. Healthcare providers who received affected product should contact McKesson Medical-Surgical with their distribution dates to determine if they received recalled vials. Affected NDC codes are 00591-2136-51 (50 mL vials in packs of 20) and 00591-2136-68 (100 mL vials in packs of 10). McKesson is unable to identify specific lot numbers for individual customers based on available records.
The recalled product
- Product
- Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Anesthetic
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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