FDAClass IIAugust 2, 2017

BUPIVacaine HCl 0.1% PF recall: Sterility Concern

BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821…

Why was BUPIVacaine HCl 0.1% PF recalled?

Lack of Assurance of Sterility; product has the potential to leak.

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?

Lots: 20170429@33 BUD: 7/28/2017, 20170503@23 BUD: 8/1/2017

Product
BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821…
Recalling firm
SCA Pharmaceuticals
Quantity
N/A
Distribution
Nationwide
Recall date
August 2, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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