Drug product
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
D-1258-2020
Product summary
- Firm
- Akorn Inc
- Event
- Event 85239
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15,170 ampules
- Official record key
drug-enforcement:D-1258-2020
Official wording
Reason: Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Code information: Lot 081887A, EXP 08/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-Specification