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Recall Observatory FDA recall evidence

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

March 25, 2020

Class III

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

    reason.potency_specification_failure · v1.0.0

    Out-of-Specification