# FDA recall D-1429-2015

> **Akorn, Inc.** · Class III · drug recall initiated 2015-04-20.

## 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) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL  60045.

## Reason for recall

Subpotent Drug: Low out-of-specification potency result of the drug product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1429-2015
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-20
- **Report date:** 2015-09-23
- **Termination date:** 2017-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1429-2015

## Citation

> AI Analytics. FDA recall D-1429-2015. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1429-2015. Source: US FDA. Licensed CC0.

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