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Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx o...

FDA Recall #D-0460-2022 — Class II — January 5, 2022

Recall #D-0460-2022 Date: January 5, 2022 Classification: Class II Status: Terminated

Product Description

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, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.

Reason for Recall

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

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

31,510 ampules

Distribution

Nationwide in the USA

Code Information

Lot # 031489A, Expiration 03/31/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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