Home / Recalls / Nephron Pharmaceuticals Corp. / D-66462-001

D-66462-001 Class II Terminated

Recalled by Nephron Pharmaceuticals Corp. — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
October 30, 2013
Initiation Date
October 2, 2013
Termination Date
August 21, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
689,568 cartons

Product Description

Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25

Reason for Recall

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15

Other recalls by Nephron Pharmaceuticals Corp.

  • Z-2053-2016 Class II — Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials p (November 16, 2015)
  • Z-2054-2016 Class II — Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, (November 16, 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-0389-2016 Class II — Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepin (August 21, 2015)
  • 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)
  • Z-1371-2013 Class I — EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications f (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)