FDA Drug recall D-0962-2015
Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)003…
- FDA Drug
- Class III
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class III recall of Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)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-0962-2015 |
| 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
Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA.
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 rose bengal present in the strips.
Identifiers
| upc | 351801004408 |
|---|---|
| ndc | 51801-004-40 |
| ndc | 51801-004-01 |
| ndc | 0035180100 |
| code_info | Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18 |
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-0962-2015%22
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