Rose Bengal GloStrips — Class III drug recall D-0962-2015
Terminated recall by Nomax Inc, reported 2015-04-29, distributed nationwide. Failed Content Uniformity Specifications: The product may not meet finished product release specifications, in
| Recall number | D-0962-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nomax Inc, Saint Louis, MO, United States |
| Recall initiated | 2015-03-24 |
| Classified | 2015-04-21 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2017-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CO, DO, HN, IL, IS, JM, TT |
| Quantity | 5,514 cartons |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00351801004019, 00351801004408 |
| NDC | 51801-0004, 51801-0004-01, 51801-0004-40 |
| Lot numbers | 04/18, 07/17, 10/17, 8925, 8972, 9195 |
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 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 rose bengal present in the strips.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0962-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.