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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29

Is my product affected?

Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29

  • Brand DIPRIVAN

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling Diprivan (Propofol) Emulsion, 200 mg per 20 mL vials, distributed nationwide across 46 cartons. The recall was initiated due to temperature abuse during storage or handling that violated current good manufacturing practice (cGMP) standards. Because McKesson is unable to identify which specific lot numbers were received by individual customers, the company included distribution dates in recall letters to help recipients determine whether their product may have been affected.

The product involved is a prescription-only injectable medication manufactured by App Pharmaceutical LLC. The recall record does not specify what consumers or healthcare facilities should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 46 cartons Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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