Home / Recalls / Akorn, Inc. / D-0460-2022

D-0460-2022 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type: Drugs
Report Date: January 19, 2022
Initiation Date: January 5, 2022
Termination Date: September 17, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 31,510 ampules

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 031489A, Expiration 03/31/2022

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