The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1116-2022·Announced 2022-06-15

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.

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: 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
Affected units
46

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.

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.

See all 130 products in this recall →

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