|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
February 24, 1999
a) Oxygen, USP, Compressed, "H", "E", "T" and "M"
high pressure cylinders; b) Oxygen, USP, Refrigerated Liquid, in dewars (5010). Recall
a) All lot codes manufactured on 6/2/98 through 1/7/99, ranging in sequence from 20F02H to
20A07I; b) All lot codes manufactured on 6/2/98 through 1/7/99, ranging in sequence from
20F02H to 20A07I.
DeLille Oxygen Company, Zanesville, Ohio.
Manufacturer, initially on January 11, 1999, and by letter on January 29, 1999.
Firm-initiated recall ongoing.
Current good manufacturing practice deviations; including lack of assay/potency equipment
calibrations, production records missing, and incorrect expiration dating.