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

Mckesson Medical-Surgical Inc. Corporate Office: Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10

Is my product affected?

Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10

  • Brand AMPICILLIN

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

What happened

McKesson Medical-Surgical Inc. is recalling Ampicillin for Injection, USP, 1 gram per vial in 10-count boxes distributed nationwide by Auromedics Pharma. The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations involving temperature abuse of the product. Approximately 10 cartons containing 10 vials each were affected by this issue.

The recall notice does not specify a specific lot number for the affected product. Instead, McKesson Medical-Surgical states it is unable to identify the particular lot numbers received by specific customers, and notes that individual notification letters include the distribution date and the dates when potentially affected product may have been shipped to each customer. The source does not specify what action affected consumers should take.

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: 10 cartons/10 vials each 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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