Recall Z-2053-2016 ยท CAF Nebulizer (Direct Patient Interface)
Nephron Pharmaceuticals Corp.
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. 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
| Date | Jun 27, 2016 (initiated Nov 16, 2015) |
| Status | Terminated |
| Reason | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. |
| Root cause | Process control |
| Action | Nephron Pharmaceuticals Corporation sent an Urgent Drug Recall letter to all affected customers on November 16, 2015. The letter identified the product, the problem, and the action to be taken by the customer. NPC requested customers remove the affected lots from their inventory, including store shelves. Customers with questions should call 1-844-374-6841 |
| Quantity | 11,208 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML Nephron Pharmaceuticals Corp., Apr 20, 2012 |