Sodium Chloride Inhalation Solution recall: Sterility Concern
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…
Why was Sodium Chloride Inhalation Solution recalled?
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number N4753A, Exp 11/16
- 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…
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Quantity
- 13,692 cartons
- Distribution
- Worldwide Distribution - US including 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 and Internationally to Canada.
- Recall date
- July 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)