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
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
Lot numbers, UPCs & expiration codes
Lot #s: a) 14904, Exp. 06/30/2024; Lot 14938, Exp. 07/31/2024; b) Lot 14931, Exp. 06/30/2024
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-0462-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 19, 2024
- FDA report date
- May 1, 2024
- Quantity
- 15,056 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nomax Inc
Original FDA data
Every field from FDA enforcement report D-0462-2024, 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 #s: a) 14904, Exp. 06/30/2024; Lot 14938, Exp. 07/31/2024; b) Lot 14931, Exp. 06/30/2024
- Postal code
- 63123-7241
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0462-2024
- Classification
- Class II
- Recalling firm
- Nomax Inc
- Product quantity
- 15,056 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
- GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 19, 2024
- Center classification date
- Apr 23, 2024