Reported Apr 29, 2015 · Terminated
Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode…
Nomax 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: Nomax Inc · 9735 Green Park Industrial Dr · Saint Louis, MO · 63123-7241
Is this the product you have?
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 00317478404019 | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019 |
| 2 | packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. | |
| 3 | 00360843000026 | 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 codes and dates
- 1)
- FUL-GLO Lot
8980Exp 10/159081Exp 01/169088Exp 02/169128 and 9158Exp 03/162)
- Pro Glo Lot
9082Exp 01/17
- Amount recalled
- 62,691 cartons
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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