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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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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
Distribution Pattern OK

Product Detail

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