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

Mckesson Medical-Surgical Inc. Corporate Office: Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

Is my product affected?

Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

  • Brand BUPIVACAINE HYDROCHLORIDE

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

What happened

McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride, USP 0.5% (5mg/mL) distributed nationwide across the United States. The recall affects 30 vials of this prescription medication manufactured by Pfizer due to cGMP (Current Good Manufacturing Practice) deviations involving temperature abuse during storage or handling.

The company was unable to identify the specific lot numbers received by individual customers, but notified them based on distribution dates and the timeframe when affected product may have been shipped. The source document does not specify what remedy is available to consumers affected by 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: 30 vials 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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