Prescription anesthetic Diprivan recalled for manufacturing temperature deviation
McKesson is recalling Diprivan (Propofol) injection due to manufacturing temperature deviations that may affect drug stability. The FDA Class II recall involves 122 cartons distributed nationwide to medical settings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing temperature deviation of an intravenous anesthetic. Meets the Score 3 (High) rubric criterion: risk-of-harm product where injury has not been reported.
Plain-English summary
Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vials are being recalled by McKesson Medical-Surgical Inc. The recalled product was manufactured by Fresenius Kabi USA, LLC, with a total of 122 cartons affected. The product is an intravenous anesthetic and sedative used in medical facilities.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations, specifically temperature abuse during the manufacturing process. Temperature exposure during manufacturing can compromise a drug's stability and efficacy, raising concerns about the product's performance in clinical use.
The product was distributed nationwide across the United States. McKesson states it is unable to identify specific lot numbers received by particular customers, and has notified affected consignees with the dates their shipments may have been impacted.
Healthcare facilities and providers in possession of affected Diprivan should discontinue use and contact McKesson Medical-Surgical for return and replacement instructions. The FDA is monitoring the recall.
The recalled product
- Product
- DIPRIVAN (PROPOFOL)
- Brand
- DIPRIVAN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Anesthetic
- Hazard
- temperature-damage
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (4)
- 0363323269302
- 0363323269357
- 0363323269012
- 0363323269227
Distribution
Distributed nationwide across the United States.
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