Reported Apr 29, 2015 · Terminated
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped…
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?
4 of 4 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 00351801003012 | Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in |
| 2 | 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and | |
| 3 | 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and | |
| 4 | 00317478403036 | FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045. |
- Lot codes and dates
- 1)
- GloStrips Lot
a) 9031Exp 12/17b) 9023Exp 11/179065Exp 01/189127 and 9132Exp 03/18
- and 2) Ful-Glo Lot
9050Exp 12/189113Exp 02/19and 9206Exp 05/19
- Amount recalled
- 23,201 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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