Home / Recalls / Nephron Pharmaceuticals Corp. / Z-2053-2016

Z-2053-2016 Class II Terminated

Recalled by Nephron Pharmaceuticals Corp. — Orlando, FL

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

Other recalls by Nephron Pharmaceuticals Corp.

  • Z-2054-2016 Class II — Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, (November 16, 2015)
  • D-0389-2016 Class II — Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepin (August 21, 2015)
  • D-0010-2016 Class II — Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packa (August 21, 2015)
  • D-0388-2016 Class II — Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Rac (August 21, 2015)
  • D-66462-001 Class II — Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation O (October 2, 2013)
  • Z-1371-2013 Class I — EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications f (April 30, 2013)
  • Z-1373-2013 Class I — EZ Breathe Medication Cup. For the delivery of liquid medications for respira (April 30, 2013)
  • Z-1372-2013 Class I — AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Bre (April 30, 2013)
  • D-1446-2012 Class II — Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Via (June 22, 2011)