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Class III: unlikely to cause harmTerminated

Akorn Fentanyl Citrate Injection Recall

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL…

Akorn Inc · Lake Forest, IL

Risk level
Class III
Reported by FDA
May 1, 2019
Recall ID
D-1241-2019
Check your lot numberHow we source this data

Summary

Akorn recalled Fentanyl Citrate Injection starting Apr 23, 2019. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1241-2019 on May 1, 2019. Reason: Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing. Status: Terminated.

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.

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 011198, Exp 01/22

Where it was sold

U.S.A. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1241-2019
Classification
Class III
Status
Terminated
Recall initiated
Apr 23, 2019
FDA report date
May 1, 2019
Quantity
5,380 cartons (25 ampules per carton)
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn Inc

Original FDA data

Every field from FDA enforcement report D-1241-2019, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
82657
Address
1925 W Field Ct Ste 300
Code information
Lot #: 011198, Exp 01/22
Postal code
60045-4862
Report date
May 1, 2019
Product type
Drugs
Recall number
D-1241-2019
Classification
Class III
Recalling firm
Akorn Inc
Product quantity
5,380 cartons (25 ampules per carton)
Termination date
Jul 28, 2022
Reason for recall
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Apr 23, 2019
Initial firm notification
Letter
Center classification date
Apr 24, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1241-2019, published May 1, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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