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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Detail

Product Description 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
Recall Number D-1445-2012
Classification Class II
Code Info All lots distributed January 1, 2011 - October 18, 2011.
Product Distributed Qty 861 cylinders
Reason For Recall CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation

Event Detail

Event Id 62698
Product Type Drugs
Status Completed
Recalling Firm Oklahoma Respiratory Care Inc
City Norman
State OK
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-21
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern OK
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