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Class II: temporary or reversible health riskTerminated

Akorn Sufentanil Citrate Injection Recall

Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural…

Akorn, Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jan 19, 2022
Recall ID
D-0460-2022
Check your lot numberHow we source this data

Summary

Akorn recalled Sufentanil Citrate Injection starting Jan 5, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0460-2022 on Jan 19, 2022. Reason: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. Status: Terminated.

Why it was recalled

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

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.

Lot numbers, UPCs & expiration codes

Lot # 031489A, Expiration 03/31/2022

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0460-2022
Classification
Class II
Status
Terminated
Recall initiated
Jan 5, 2022
FDA report date
Jan 19, 2022
Quantity
31,510 ampules
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0460-2022, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
89361
Address
1925 W Field Ct Ste 300
Code information
Lot # 031489A, Expiration 03/31/2022
Postal code
60045-4862
Report date
Jan 19, 2022
Product type
Drugs
Recall number
D-0460-2022
Classification
Class II
Recalling firm
Akorn, Inc.
Product quantity
31,510 ampules
Termination date
Sep 17, 2022
Reason for recall
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA
Recall initiation date
Jan 5, 2022
Initial firm notification
E-Mail
Center classification date
Jan 27, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0460-2022, published Jan 19, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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