FDAClass IIFebruary 28, 2018

Bupivacaine HCl in 0.9% Sodium Chloride in all doses recall: Sterility Concern

Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.

Why was Bupivacaine HCl in 0.9% Sodium Chloride in all doses recalled?

Lack of sterility assurance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots remaining within expiry.

Product
Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
Recalling firm
Pharmedium Services, LLC
Quantity
297 bags
Distribution
U.S.A. Nationwide
Recall date
February 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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