Home / Recalls / Nephron Pharmaceuticals Corp. / D-0388-2016

D-0388-2016 Class II Terminated

Recalled by Nephron Pharmaceuticals Corp. — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
December 9, 2015
Initiation Date
August 21, 2015
Termination Date
February 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47,754 cartons

Product Description

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10

Reason for Recall

Discoloration

Distribution Pattern

Nationwide

Code Information

Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015)

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-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-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)