Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warni
Summary
The FDA issued a Class II for Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and e by Akorn, Inc.. Reason: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint..
Details
Source
Drug Recall
External ID
D-0460-2022
Action Date
2022-01-19
Status
Terminated
Category
drug
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/Code Info: Lot # 031489A, Expiration 03/31/2022
Quantity Affected: 31,510 ampules
Reason for Recall
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-05
Company
Lake Forest, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 66 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Akorn, Inc. has 130 FDA actions in our database, including 130 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Akorn, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akorn, Inc. have FDA actions?
Akorn, Inc. has 130 FDA actions in our database, including 130 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0460-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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