FDAClass IIFebruary 27, 2019

Fentanyl in 0.9% Sodium Chloride QS recall: Labeling Error

Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only…

Why was Fentanyl in 0.9% Sodium Chloride QS recalled?

Labeling: Incorrect expiration date.

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#: 12/31/18 0555 21072S, Exp 3/31/2019

Product
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only…
Recalling firm
Advanced Pharma Inc.
Quantity
100 syringes
Distribution
PA
Recall date
February 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls