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

Mckesson Medical-Surgical Inc. Corporate Office: Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-10

Is my product affected?

Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-10

  • 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 100 mg/mL in 10mL vials distributed nationwide due to temperature abuse that violated current good manufacturing practice (cGMP) standards. The recall involves 122 cartons of the product manufactured by App Pharmaceutical LLC. McKesson has not been able to identify the specific lot numbers received by individual customers, but has provided distribution dates and possible shipment dates to affected customers in individual letters.

The source document does not specify a remedy or recommended action for consumers who may have received this product.

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: 122 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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