Propofol Injectable Anesthetic Recalled for Temperature Abuse Manufacturing Deviations
McKesson Medical-Surgical is recalling DIPRIVAN (Propofol) injectables nationwide due to temperature abuse during distribution that may have affected product stability. The recall involves 46 cartons.
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: This is an FDA Class II recall involving a manufacturing practice deviation (temperature abuse) of an injectable medication. No illnesses, injuries, or confirmed contamination have been reported, keeping the score to at most 3; the Class II classification and absence of reported harm indicate a moderate rather than high severity.
Plain-English summary
DIPRIVAN (Propofol) is a prescription intravenous anesthetic used for sedation and anesthesia in medical and surgical settings. The recalled product is Propofol Emulsion, 200 mg per 20 mL vials (10 mg/mL), with approximately 46 cartons distributed nationwide by McKesson Medical-Surgical Inc.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations related to temperature abuse during distribution and storage. Temperature exposure outside acceptable parameters may have compromised the product's stability and integrity.
Healthcare providers and facilities that received the product should check the distribution dates provided in their individualized recall letters from McKesson to determine if they received affected inventory. Because specific lot numbers could not be identified by facility, personalized notices were sent with applicable shipment dates. Affected product should be quarantined and not used.
The recalled product
- Product
- DIPRIVAN (PROPOFOL)
- Brand
- DIPRIVAN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Anesthetic
- Hazard
- temperature-abuse
- 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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