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.
Reported: January 19, 2022 Initiated: January 5, 2022 #D-0460-2022
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.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 31,510 ampules
- Distribution
- Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn, Inc.. Units affected: 31,510 ampules.
Why was this product recalled? ▼
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 19, 2022. Severity: Moderate. Recall number: D-0460-2022.
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