December 2012 FDA Recall Drug by Oklahoma Respiratory Care Inc
D-818-2013 - Failed impurities/degradation specifications

This Class II drug recall was voluntarily initiated by Oklahoma Respiratory Care Inc on December 5, 2012 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Oklahoma and the recall is currently terminated.

Recall Number: D-818-2013

Reason for Recall
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Initiated
12-05-2012
Reported
07-31-2013
Quantity
94 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65621
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.
Oklahoma Respiratory Care 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.
Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Oklahoma
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071

Batch or Lot Expiration Information

Lot# Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.