Drug product
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.
D-0460-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 89361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,510 ampules
- Official record key
drug-enforcement:D-0460-2022
Official wording
Reason: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Code information: Lot # 031489A, Expiration 03/31/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent