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

Mckesson Medical-Surgical Inc. Corporate Office: Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3103-11

Is my product affected?

Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3103-11

  • Brand CEFAZOLIN SODIUM

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

What happened

McKesson Medical-Surgical Inc. is recalling Cefazolin for Injection USP and Dextrose Injection USP in 1G, 50 mL duplex containers due to temperature abuse during manufacturing that violated good manufacturing practices. The affected product was manufactured by B. Braun Medical Inc. and distributed nationwide to customers in 26 cases. Because McKesson cannot identify which specific lot numbers were received by individual customers, each recall notification letter specifies the distribution date to that customer and the dates when affected product may have been shipped to them.

The source document does not specify what action affected consumers or healthcare facilities should take regarding 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: 26 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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