Recall D-1241-2019
- Product type
- Drugs
- Firm
- Akorn Inc
- Status
- Ongoing
- Classification
- Class III
- Product
- Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
- Reason
- Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
- Distribution
- U.S.A. Nationwide
- Report date
- 2019-05-01