NDC 17478-030

Fentanyl Citrate 50 ug per 1 mL injection, solution

On the label: Akorn.

Where it's made

Akorn

Location not on file · makes it, tests it and sterilizes it

Not inspected on record

Akorn

Location not on file · packages it and labels it

Not inspected on record

Recalls

• Mar 25, 2020 · Class III · Terminated
  Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
  Lots: Lot 081887A, EXP 08/2021
• Apr 23, 2019 · Class III · Terminated
  Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
  Lots: Lot #: 011198, Exp 01/22

Product details

Generic drug

Fentanyl: see every company that makes it

Form

injection, solution

Strength

50 ug per 1 mL

Approval

NDA NDA016619

On the market since

Mar 22, 2012

Package NDCs

17478-030-02 17478-030-05 17478-030-10 17478-030-20 17478-030-25 17478-030-55

Official label

DailyMed (National Library of Medicine), updated Sep 9, 2022

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?