FDAFDA · Food and drugs·Recall number D-0460-2022
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.
Published January 19, 2022 · Recall initiated: January 5, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot # 031489A, Expiration 03/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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