FDAClass IINovember 8, 2017

fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% recall: Sterility Concern

fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA…

Why was fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% recalled?

Lack Of Assurance Of Sterility.

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?

Lot: 20170814@20 BUD: 11/12/2017

Product
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA…
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
116 bags
Distribution
Nationwide in the United States
Recall date
November 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls