Ciprofloxacin Ophthalmic Solution — Class III drug recall D-1060-2016
Terminated recall by Actavis Pharma Inc, reported 2016-07-06, distributed nationwide. Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification r
| Recall number | D-1060-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Pharma Inc, Parsippany, NJ, United States |
| Recall initiated | 2016-03-16 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 447,150 bottles |
| Reason classes | specification failure |
| NDC | 50383-0282-02, 50383-0282-05, 50383-0282-10 |
| Expiration dates | 2016-03-31, 2016-05-31, 2016-06-30, 2016-07-31, 2016-08-31, 2016-09-30, 2016-10-31, 2016-12-31, 2017-02-28, 2017-04-30, 2017-08-31, 2017-09-30, 2017-10-31 |
Product
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10
Reason for recall
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
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-1060-2016. 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.