Reported May 1, 2019 · Terminated
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured…
Akorn Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn Inc · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only
- Manufactured byAkorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
- Lot codes and dates
Lot #: 011198Exp 01/22
- Amount recalled
- 5,380 cartons (25 ampules per carton)
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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