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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 24, 1999

PRODUCT
a) Oxygen, USP, Compressed, "H", "E", "T" and "M" high pressure cylinders; b) Oxygen, USP, Refrigerated Liquid, in dewars (5010). Recall #D-111/112-9.

CODE
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.

MANUFACTURER
DeLille Oxygen Company, Zanesville, Ohio.

RECALLED BY
Manufacturer, initially on January 11, 1999, and by letter on January 29, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Ohio.

QUANTITY

Undetermined.

REASON
Current good manufacturing practice deviations; including lack of assay/potency equipment calibrations, production records missing, and incorrect expiration dating.

 

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.