FDAClass IIJanuary 19, 2022

Sufentanil Citrate Injection recall: Subpotent

Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming…

Why was Sufentanil Citrate Injection recalled?

Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.

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 # 031489A, Expiration 03/31/2022

Product
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming…
Recalling firm
Akorn, Inc.
Quantity
31,510 ampules
Distribution
Nationwide in the USA
Recall date
January 19, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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