Sodium Chloride Ophthalmic Solution — Class II drug recall D-0124-2017
Terminated recall by Akorn Inc, reported 2016-11-09, distributed nationwide. Subpotent Drug: concentration of product is less than labeled amount.
| Recall number | D-0124-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2016-10-21 |
| Classified | 2016-11-02 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2019-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 29,972 bottles |
| Reason classes | labeling, potency |
| NDC | 17478-0623-12 |
| Lot numbers | 04/19, 041306A |
Product
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Reason for recall
Subpotent Drug: concentration of product is less than labeled amount.
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-0124-2017. 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.