FDAFDA · Food and drugs·Recall number D-1258-2020
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
Published April 8, 2020 · Recall initiated: March 25, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot 081887A, EXP 08/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.