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

Mckesson Medical-Surgical Inc. Corporate Office: Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-09

Is my product affected?

Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-09

  • Brand INTRALIPID

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

What happened

McKesson Medical-Surgical Inc. is recalling Intralipid (I.V. Fat emulsion), 20%, 250 mL bags manufactured by Baxter Healthcare. The recall affects 5 cases distributed nationwide across the United States due to temperature abuse during storage or handling, which violates current good manufacturing practice (cGMP) standards. Because McKesson Medical-Surgical cannot identify the specific lot numbers received by individual customers, they are providing distribution dates and potential shipment dates in recall letters to help locate affected product.

The source document does not specify a remedy for affected consumers or healthcare facilities holding 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: 5 cases 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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