Reported Sep 23, 2015 · Terminated
IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count…
Akorn, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W. Field Court, Suite 300 · Lake Forest, IL · 60045
Is this the product you have?
- 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 byAkorn, Inc., Lake Forest, IL 60045
- Lot codes and dates
- Lot #:
- Kit071374
- IC-Green
041514Exp 10/16
- Amount recalled
- 370 kits
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Low out-of-specification potency result of the drug product.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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