Why it was recalled
Subpotent Drug: Low out-of-specification potency result of the drug product.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1429-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 20, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 370 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1429-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71737
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16
- Postal code
- 60045
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1429-2015
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 370 kits
- Termination date
- Jan 26, 2017
- Reason for recall
- Subpotent Drug: Low out-of-specification potency result of the drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 20, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2015