D-1383-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 27, 2012
- Initiation Date
- May 4, 2012
- Termination Date
- June 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 283 cylinders
Product Description
LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
Reason for Recall
CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Distribution Pattern
Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.
Code Information
LOT#: 117H201 LOT#: 117H202