Sodium Chloride Inhalation Solution — Class II medical device recall Z-2054-2016
Terminated recall by Nephron Pharmaceuticals Corp., reported 2016-07-06, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
| Recall number | Z-2054-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Pharmaceuticals Corp., Orlando, FL, United States |
| Recall initiated | 2015-11-16 |
| Classified | 2016-06-27 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-01-09 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | CA |
| Quantity | 13,692 cartons |
| Reason classes | sterility |
| NDC | 00487-9007-60 |
| Lot numbers | 11/16, N4753A |
Product
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
Reason for recall
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
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/Z-2054-2016. 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.