FDAClass IIJuly 4, 2018

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP recall: Subpotent

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B…

Why was fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP recalled?

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

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 #: 6/12/18 0432 149-21072S, BUD 9/10/18

Product
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B…
Recalling firm
Advanced Pharma Inc.
Quantity
100 syringes
Distribution
Distributed to one medical center in Fort Worth, TX.
Recall date
July 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls