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Class III: unlikely to cause harmTerminated

Akorn IC-Green Recall

IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing si…

Akorn, Inc. · Lake Forest, IL

Risk level
Class III
Reported by FDA
May 17, 2017
Recall ID
D-0697-2017
Check your lot numberHow we source this data

Summary

Akorn recalled IC-Green starting Apr 20, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0697-2017 on May 17, 2017. Reason: Product is being recalled due to low pH value. Status: Terminated.

Why it was recalled

Product is being recalled due to low pH value.

Product description

IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02

Lot numbers, UPCs & expiration codes

Kit Lot #031126; Exp 8/2018

Where it was sold

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-0697-2017
Classification
Class III
Status
Terminated
Recall initiated
Apr 20, 2017
FDA report date
May 17, 2017
Quantity
1,292 kits
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0697-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
77071
Address
1925 W Field Ct Ste 300
Code information
Kit Lot #031126; Exp 8/2018
Postal code
60045-4862
Report date
May 17, 2017
Product type
Drugs
Recall number
D-0697-2017
Classification
Class III
Recalling firm
Akorn, Inc.
Product quantity
1,292 kits
Termination date
Feb 21, 2019
Reason for recall
Product is being recalled due to low pH value.
Voluntary / mandated
Voluntary: Firm initiated
Product description
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
Distribution pattern
Nationwide
Recall initiation date
Apr 20, 2017
Initial firm notification
Letter
Center classification date
May 9, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0697-2017, published May 17, 2017. 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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