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
This recall has been terminated (originally issued June 27, 2016).
- Company
- Nephron Pharmaceuticals Corp.
- Recall Initiated
- November 16, 2015
- Posted
- June 27, 2016
- Terminated
- January 9, 2017
- Recall Number
- Z-2053-2016
- Quantity
- 11,208 cartons
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
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.
Lot / Code Info
Lot Number N4745A, Exp 09/16
Root Cause
Process control
Action Taken
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