Ciprofloxacin OPTH 0 — Class III drug recall D-1061-2016
Terminated recall by Aidarex Pharmaceuticals LLC, reported 2016-07-06, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
| Recall number | D-1061-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aidarex Pharmaceuticals LLC, Corona, CA, United States |
| Recall initiated | 2016-06-01 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2016-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 599 bottles |
| Reason classes | specification failure |
| NDC | 33261-0614-01, 33261-0910-01 |
| Expiration dates | 2016-05, 2016-08, 2016-09, 2016-10, 2017-02 |
Product
Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
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-1061-2016. 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.