June 2012 FDA Recall Drug by Oklahoma Respiratory Care Inc
D-1445-2012 - CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation

This Class II drug recall was voluntarily initiated by Oklahoma Respiratory Care Inc on June 21, 2012 for the product Drug. The FDA reported the reason for recall as cgmp deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation. The product was distributed in OK and the recall is currently terminated.

Recall Number: D-1445-2012

Reason for Recall
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Initiated
06-21-2012
Reported
08-15-2012
Quantity
861 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62698
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.
OK
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-02-2013
Product Description About Product Description
Full technical description of the product.
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK

Batch or Lot Expiration Information

Lot# All lots distributed January 1, 2011 - October 18, 2011.