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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
November 18, 1998

PRODUCT
a) Metaproterenol Sulfate Inhalation Solution, USP, 0.4%, in 2.5 mL Arm-a-Med Plastic Vials, NDC 0186-4131 -01; b) Metaproterenol Sulfate Inhalation Solution, USP, 0.6%, in 2.5 mL Arm-a-Med Plastic Vials, NDC 0186-4130-01 c) Sodium Chloride Solution, 0.45% for Respiratory Therapy, 3 mL Arm-a-Vial Plastic Vials, NDC 0186-4101-01, and in 5 mL Arm-a-Vial Plastic Vials, NDC 01 86-4101-03; d) Sodium Chloride Solution, 0.9% for Respiratory Therapy, in 3 mL Arm-a-Vial Plastic Vials, NDC 0 1 86-41 00-01, and in 5 mL Arm-a-Vial Plastic Vials, NDC 0 1 86-4100-03; e) Sterile Water for Respiratory Therapy in 3 mL Arm-a-Med Plastic Vials, NDC 0186-4102-01, and in 5 mL Arm-a-Vial Plastic Vials, NDC 0 1 86-4102-03. Recall #D-013/017-9.

CODE
Lot numbers: a) P33410 (EXP 10/98) and R33508 (EXP 8/99); b) P26010 (EXP 10/98) and R26311 (EXP 11/99); c) R65209 (EXP 9/99) and N62611 (EXP 11/98); d) P53909 (EXP 9/98), R54107 (EXP 7/99), R54208 (EXP 8/99), R54308 (EXP 8/99), R54408 (EXP 9/99), R54509 (EXP 9/99), R54609 (EXP 9/99), R54709 (EXP 9/99), R54810 (EXP 10/99), R54910 (EXP 10/99), R55010 (EXP 10/99), R55110 (EXP 10/99), R55311 (EXP 11/99), R55412 (EXP 12/99), R55512 (EXP 12/99), N42309 (EXP 9/98), N42409 (EXP 9/98), N42509 (EXP 9/98), N42610 (EXP 10/98),N42711 (EXP 11/98), N42811 (EXP 11/98), P42902 (EXP 2/99), P43006 (EXP 6/99), P43210 (EXP 10/99), P43311 (EXP 11/99), R43407 (EXP 7/00), R43507 (EXP 7/00), R43607 (EXP 7/00), R43709 (EXP 9/00) and R43810 (EXP 1 0/00); e) R76911 (EXP 11/00) and P71809 (EXP 8/99).

MANUFACTURER
Centeon L.L.C. Kankakee, Illinois (contract manufacturer).

RECALLED BY Manufacturer, by letter October 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Volume of Product in Commerce:
NACL 0.9%  5 mL: 49,336 units
NACL 0.9%  3 mL: 41,790 units
NACL 0.45% 3 mL: 1,939 units
NACL 0.45% 5 mL: 967 units
Metaproterenol Sulfate 0.6% 2.5 mL: 815 units
Metaproterenol Sulfate 0.4% 2.5 mL: 1,390 units
Sterile Water for Respiratory Therapy 5 mL: 460 units
Sterile Water for Respiratory Therapy 5 mL: 529 units

REASON
Some vials exhibit pin-hole leaks.

 

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.