Akorn, Inc.: Drug Recall
Recall #D-0460-2022 · 01/05/2022
Class II: Risk
Recall Details
- Recall Number
- D-0460-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Terminated
- Date Initiated
- 01/05/2022
- Location
- Lake Forest, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,510 ampules
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Other Recalls by Akorn, Inc.
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.