The Recall Desk
LowFDA (Drugs)·D-1429-2015·Announced 2015-09-23

Akorn Recalls IC-Green Injection Kits Due to Low Potency

Akorn, Inc. is recalling 370 kits of IC-Green (indocyanine green for injection) because a low out-of-specification potency result was found.

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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Akorn, Inc. is recalling 370 kits of IC-GREEN (indocyanine green for injection, USP), 25 mg. The recall is being conducted because a low out-of-specification potency result was identified for the drug product. The affected product is an Rx-only kit containing 6-count IC-Green Vials 25 mg and 6-count 10 mL Sterile Aqueous Solvent Ampules.

The recall covers Lot 071374 for the kits, with an expiration date of 10/16. The product was distributed nationwide. The agency has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected product and contact Akorn, Inc. or their supplier for instructions on how to return the product.

The recalled product

Product
IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) pe
Manufacturer
Akorn, Inc.
Category
Drug — Injection
Hazard
Affected units
370

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 (3)

  • Lot #: Kit: 071374
  • IC-Green: 041514
  • Exp 10/16

Distribution

Distributed nationwide across the United States.

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