Rose Bengal 1% Ophth Solution — Class II drug recall D-0789-2016
Terminated recall by Walter's Pharmacy, reported 2016-04-06, distributed in PA. Lack of Assurance of Sterility
| Recall number | D-0789-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Walter's Pharmacy, Allentown, PA, United States |
| Recall initiated | 2016-02-12 |
| Classified | 2016-03-29 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-01-06 |
| Distributed | PA |
| Quantity | 3 bottles |
| Reason classes | sterility |
| Lot numbers | 012516 |
Product
Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706
Reason for recall
Lack of Assurance of Sterility
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-0789-2016. 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.