FDA Drug recall D-0961-2015
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-…
- FDA Drug
- Class III
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class III recall of Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-… by Nomax, citing failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation relat….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0961-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-03-24 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nomax |
| Distribution | US |
Product
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) 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.
Reason
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.
Identifiers
| upc | 351801003401 |
|---|---|
| upc | 351801003500 |
| upc | 317478403036 |
| ndc | 51801-003-50 |
| ndc | 51801-003-40 |
| ndc | 51801-003-01 |
| ndc | 0035180100 |
| ndc | 0031747840 |
| ndc | 17478-403-03 |
| code_info | 1) GloStrips Lot: a) 9031, Exp 12/17; b) 9023, Exp 11/17; 9065, Exp 01/18; 9127 and 9132, Exp 03/18; and 2) Ful-Glo Lot…1) GloStrips Lot: a) 9031, Exp 12/17; b) 9023, Exp 11/17; 9065, Exp 01/18; 9127 and 9132, Exp 03/18; and 2) Ful-Glo Lot: 9050, Exp 12/18; 9113, Exp 02/19; and 9206, Exp 05/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0961-2015%22
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