Why it was recalled
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Product description
Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and 2)Fluorescein Pro Glo Strips, individually wrapped strips, barcode (01)00360843000026, packaged in 300-count strips per carton, (NDC 60843-300-50), UPC 3 60843 30050 8, Manufactured for Eye Care and Cure by Nomax, Inc., St. Louis, MO 63123.
Lot numbers, UPCs & expiration codes
1) FUL-GLO Lot: 8980, Exp 10/15; 9081, Exp 01/16; 9088, Exp 02/16; 9128 and 9158, Exp 03/16; 2) Pro Glo Lot: 9082, Exp 01/17
Where it was sold
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
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-0963-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 24, 2015
- FDA report date
- Apr 29, 2015
- Quantity
- 62,691 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nomax Inc
Original FDA data
Every field from FDA enforcement report D-0963-2015, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 70552
- Address
- 9735 Green Park Industrial Dr
- Code information
- 1) FUL-GLO Lot: 8980, Exp 10/15; 9081, Exp 01/16; 9088, Exp 02/16; 9128 and 9158, Exp 03/16; 2) Pro Glo Lot: 9082, Exp 01/17
- Postal code
- 63123-7241
- Report date
- Apr 29, 2015
- Product type
- Drugs
- Recall number
- D-0963-2015
- Classification
- Class III
- Recalling firm
- Nomax Inc
- Product quantity
- 62,691 cartons
- Termination date
- Feb 21, 2017
- Reason for recall
- Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and 2)Fluorescein Pro Glo Strips, individually wrapped strips, barcode (01)00360843000026, packaged in 300-count strips per carton, (NDC 60843-300-50), UPC 3 60843 30050 8, Manufactured for Eye Care and Cure by Nomax, Inc., St. Louis, MO 63123.
- Distribution pattern
- Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
- Recall initiation date
- Mar 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2015