Why it was recalled
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Product description
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Lot numbers, UPCs & expiration codes
Lot 14842, Exp. 6/30/2024
Where it was sold
Nationwide in the USA
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-0464-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 19, 2024
- FDA report date
- May 1, 2024
- Quantity
- 4648 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nomax Inc
Original FDA data
Every field from FDA enforcement report D-0464-2024, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 94461
- Address
- 9735 Green Park Industrial Dr
- Code information
- Lot 14842, Exp. 6/30/2024
- Postal code
- 63123-7241
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0464-2024
- Classification
- Class II
- Recalling firm
- Nomax Inc
- Product quantity
- 4648 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 19, 2024
- Center classification date
- Apr 23, 2024