FDAClass IIDecember 21, 2016

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in recall: Sterility Concern

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only…

Why was Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in recalled?

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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: 8942 BUD: 2/19/2017, Lot: 9207 BUD: 4/17/2017

Product
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only…
Recalling firm
Cantrell Drug Company
Quantity
2889 bags
Distribution
Nationwide
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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