Z-2053-2016 Class II Terminated
FDA device recall Z-2053-2016 was initiated by Nephron Pharmaceuticals Corp. on November 16, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. The recall status is terminated (terminated January 9, 2017). Affected quantity: 11,208 cartons.
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- November 16, 2015
- Termination Date
- January 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,208 cartons
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Distribution Pattern
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.
Code Information
Lot Number N4745A, Exp 09/16