The Recall Desk
LowFDA (Drugs)·D-0697-2017·Announced 2017-05-17

Akorn Recalls IC-Green Injection Kits Due to Low pH Value

Akorn, Inc. is recalling 1,292 kits of IC-Green (indocyanine green for injection) due to low pH values. The product was distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences, aligning with the 'Low' severity criterion for minor or theoretical risks.

Plain-English summary

Akorn, Inc. is recalling 1,292 kits of IC-Green (indocyanine green for injection, USP), 25 mg. The product is packaged in a kit containing six vials of 25 mg lyophilized powder and is available by prescription only. The specific lot number is 031126, with an expiration date of 8/2018.

The recall was initiated because the product was found to have a low pH value. The affected kits were distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
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
Manufacturer
Akorn, Inc.
Category
Drug — Injection
Hazard
Affected units
1,292

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Kit Lot #031126
  • Exp 8/2018

Distribution

Distributed nationwide across the United States.

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Same manufacturer · Akorn, Inc.

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Same hazard · low ph

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