Mckesson Medical-Surgical Inc. Corporate Office: Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

Is my product affected?

Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

• Brand BUPIVACAINE HYDROCHLORIDE

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

What happened

McKesson Medical-Surgical Inc. is recalling Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (manufactured by Auromedics Pharma LLC) distributed nationwide in the United States. The recall involves 224 cartons containing 10 vials each and was initiated due to cGMP deviations involving temperature abuse of the product.

McKesson Medical-Surgical is unable to identify the specific lot number received by individual customers. The company has sent letters to affected consignees that include the distribution date and the dates when impacted product may have been shipped to them. The source document does not specify a remedy or recommended action for affected consumers.

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: 224 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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