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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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)…
- 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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