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

Mckesson Medical-Surgical Inc. Corporate Office: Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-58

Is my product affected?

Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-58

  • 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%, 100 mL bags, a prescription medication manufactured by Baxter Healthcare. The recall involves 2 cases distributed nationwide across the USA. The product is being recalled due to cGMP deviations related to temperature abuse during storage or handling.

McKesson Medical-Surgical indicates it cannot identify the specific lot number received by individual customers. The company is providing distribution dates to customers in recall letters, including when the potentially affected product may have been shipped. The recall notice does not specify what affected consumers should do regarding the recalled 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: 2 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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