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.
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 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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