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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 10, 1999

PRODUCT
Oxygen, USP, Rx, compressed, in high pressure cylinders, E, D,
and A size;
Oxygen, USP, Rx, liquefied, in GP-4500 and GP-5500 vessels;
Medical Air, USP, Rx, compressed, in high pressure cylinders,
Size 233.  Recall #D-129/131-9.

CODE
Medical Air USP:      18L981     18L982    01M981    02M981
Medical Oxygen USP:   05L981     05L982   05L983     06L981
                      18L981      18L982   01M981    02M981
                      02M982     04M981    04M982    07M981
                      07M982     07M983    07M984    07M985
                      07M986     08M981    08M982.

MANUFACTURER
Red Ball Oxygen Co., Inc., Shreveport, Louisiana.

RECALLED BY
Manufacturer, by fax followed by letter dated December 18, 1998, and telephone. Firm-initiated recall ongoing.

DISTRIBUTION
Arkansas, Louisiana, Texas.

QUANTITY
a) 1,008 cylinders; b) 6 cylinders; c) 2 cylinders were distributed.

REASON
Current good manufacturing practice deviations including but not limited to: Lack of documented assay results for purity and identity and Lack of equipment calibration 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.