D-818-2013 Class II Terminated
FDA drug recall D-818-2013 was initiated by Oklahoma Respiratory Care Inc on December 5, 2012 and is designated Class II. Reason for recall: Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. The recall status is terminated (terminated November 4, 2014). Affected quantity: 94 cylinders.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2013
- Initiation Date
- December 5, 2012
- Termination Date
- November 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94 cylinders
Product Description
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
Reason for Recall
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Distribution Pattern
Oklahoma
Code Information
Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.