FDA Device recall Z-2054-2016
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60 by Nephron Pharmaceuticals, citing lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2054-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-16 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nephron Pharmaceuticals |
| Distribution | 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 |
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
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Identifiers
| code_info | Lot Number N4753A, Exp 11/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals
All Nephron Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2054-2016%22
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