FDAClass IIFebruary 14, 2018

All sterile drug preparations remaining within expiry recall: Sterility Concern

All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17…

Why was All sterile drug preparations remaining within expiry recalled?

Lack of sterility assurance.

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?

All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017)

Product
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17…
Recalling firm
Intrathecal Compounding Specialist, LLC
Quantity
Unknown.
Distribution
Nationwide
Recall date
February 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls