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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

Convacare Inc. Recalls Oxygen in D and E Size Compressed Cylinders

PRODUCT
Oxygen, USP, in D and E size compressed cylinders, Rx.
Recall #D-194-9.

CODE
All lots filled prior to Jan 1, 1999.

MANUFACTURER
Convacare Inc., Chester, South Carolina.

RECALLED BY
Manufacturer, by visit during routine patient visit beginning on or about January 20, 1999. Firm-initiated recall complete.

DISTRIBUTION
South Carolina.

QUANTITY
Less than 100 cylinders.

REASON
Current good manufacturing practice violations including but not limited to lack of calibration for test equipment, odor testing, and production records.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.