Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacture
McKesson Medical-Surgical is recalling Teva Propofol Injectable Emulsion (200 mg/20 mL, 25-vial cartons) nationwide due to temperature abuse during manufacturing that may affect product quality. A total of 564 cartons were distributed.
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 recall with no reported illnesses or injuries. While temperature abuse may compromise product quality, this is a precautionary recall issued in the absence of confirmed patient harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Propofol Injectable Emulsion, USP (200 mg per 20 mL, supplied in twenty-five 20 mL vials), manufactured by Teva Pharma USA (NDC 0591-2136-95). The recall is due to cGMP deviations involving temperature abuse during manufacturing.
A total of 564 cartons have been distributed nationwide in the United States. Because McKesson cannot identify the specific lot number received by each customer, recall letters have been sent to customers that include the date the product was distributed and dates it may have been shipped to them.
Customers should use the dates provided in their recall letter to determine if they received affected product. Affected product should be quarantined and not used. Customers should contact McKesson Medical-Surgical for return instructions and replacement product information.
The recalled product
- Product
- 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
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable anesthetic
- Hazard
- temperature-abuse
- contamination-risk
Distribution
Distributed nationwide across the United States.
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