April 2012 FDA Recall Drug by Airgas Inc
D-1371-2012 - Impurities/Degradation Products

This Class II drug recall was voluntarily initiated by Airgas Inc on April 10, 2012 for the product Drug. The FDA reported the reason for recall as impurities/degradation products. The product was distributed in Medical facilities in AZ and CA. and the recall is currently terminated.

Recall Number: D-1371-2012

Reason for Recall
Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.
Initiated
04-10-2012
Reported
06-20-2012
Quantity
123 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61947
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Airgas Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Medical facilities in AZ and CA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-22-2013
Product Description About Product Description
Full technical description of the product.
Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b) size E CGA 940 (CDUSPE), c) 50 lb CGA320 (CDUSP50, CD USP50S), d) size 160 liter (CD USP160LT350) cylinders, Rx only, Airgas, Puritan Medical, Distributed By: Airgas USA, LLC, Radnor, PA.

Batch or Lot Expiration Information

Lot# : YA02Z087A, YA02Z087B, YA02Z087C, YA02Z087D, YA02Z087E, YA02Z087F, Exp 03/27/17; YA022088A, YA022088B, YA022088C, YA022088D, YA022088E, YA022088F, YA022088G, YK01Z088A, YK01Z088B, YK01Z088C, YK01Z088D, YK01Z088E, YK01Z088F, YK01Z088G, Exp 03/28/17; YA02Z089A, YA02Z089B, YK01Z089A, YK01Z089B, Exp 03/29/17