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.
What this means for you
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
- Hazard
- temperature-abuse
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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