D-0783-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 6, 2016
- Initiation Date
- September 16, 2015
- Termination Date
- May 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 382 cylinders
Product Description
UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
Reason for Recall
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Distribution Pattern
Nationwide
Code Information
Lot # K411517501, K411517601, K411517701, K411518001, K411518101, K411518201, K411518202, K411518301, K411518302, K411518701, K411518801, K411518901, K411518902, K411519001, K411519101, K411519401, K411519501, K411519601, K411519602, K411519701, K411519801, K411520101, K411520201, K411520301, K411520302, K411520401, K411520901, K411521001, K411521002, K411521101, K411521102, K411521201, K411521501, K411521601, K411521602, K411521701, K411521702, K411521801, K411521901, K411522201, K411522301, K411522401, K411522501, K411523001, K411523101, K411523201, K411523202, K411523301, K411523601, K411523701, K411523801, K411523901, K411523902, K411524001, K411524301, K411524302, K411524401, K411522601, K411522901,