D-0460-2022 Class II Terminated
FDA drug recall D-0460-2022 was initiated by Akorn, Inc. on Jan 5, 2022 and is designated Class II. Reason for recall: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. The recall status is terminated (terminated Sep 17, 2022). Affected quantity: 31,510 ampules.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 19, 2022
- Initiation Date
- Jan 5, 2022
- Termination Date
- Sep 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,510 ampules
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 031489A, Expiration 03/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0460-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026