Recalls / Class III
Class IIID-1241-2019
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
- Affected lot / code info
- Lot #: 011198, Exp 01/22
Why it was recalled
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 5,380 cartons (25 ampules per carton)
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-04-23
- FDA classified
- 2019-04-24
- Posted by FDA
- 2019-05-01
- Terminated
- 2022-07-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1241-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.