FDAClass IIAugust 15, 2018

10 mcg/mL Fentanyl Citrate recall: CGMP Deviations

10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative…

Why was 10 mcg/mL Fentanyl Citrate recalled?

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

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 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018

Product
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative…
Recalling firm
PharMEDium Services, LLC
Quantity
230 Intravia Bags
Distribution
Product was distributed throughout the United States
Recall date
August 15, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls