The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0460-2022·Announced 2022-01-19

Sufentanil Citrate Injection Recalled for Subpotency

Akorn, Inc. is recalling Sufentanil Citrate Injection 100 mcg/2 mL due to subpotency—the drug was found to be out of specification for assay at the 30-month stability timepoint. Affected lot 031489A, with expiration 03/31/2022, was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall of a prescription drug. No illnesses, injuries, or hospitalizations are reported in the source text. The hazard is a subpotency issue (out-of-specification assay), which represents a deviation from product quality standards. Without reported adverse events, the score does not rise above Moderate per the rubric.

Plain-English summary

Akorn, Inc. is recalling Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use. The drug is a prescription opioid used for pain management and is preservative-free and supplied in 2 mL ampules (NDC 17478-0050-02).

The recall was initiated because the drug was found to be subpotent—meaning it contained less active ingredient than specified—when tested at the 30-month stability timepoint. This out-of-specification assay result indicates the drug may not deliver the intended therapeutic dose.

The affected lot is #031489A with an expiration date of 03/31/2022. Approximately 31,510 ampules were distributed nationwide throughout the United States.

Patients and healthcare providers who have this lot should contact their pharmacist or healthcare provider. Do not use this medication without consulting a healthcare professional about whether a replacement or alternative is appropriate.

The recalled product

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, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Manufacturer
Akorn, Inc.
Category
Drug — Opioid / Injectable
Hazard
Affected units
31,510

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 031489A
  • Expiration 03/31/2022

Distribution

Distributed nationwide across the United States.

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