Home / Recalls / Nephron Pharmaceuticals Corp. / D-0010-2016

D-0010-2016 Class II Terminated

Recalled by Nephron Pharmaceuticals Corp. — Orlando, FL

Recall Details

Product Type: Drugs
Report Date: October 21, 2015
Initiation Date: August 21, 2015
Termination Date: February 10, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 85,248 cartons and b) 35,292 cartons

Product Description

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL

Reason for Recall

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

Distribution Pattern

Nationwide

Code Information

a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016

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-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)
D-66462-001 Class II — Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation O (October 2, 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)
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)