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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 6, 1998

PRODUCT
Decadron Phosphate Injection (Dexamethasone Sodium Phosphate), 4 mg per mL in 1 mL and 2 mL vials, in boxes of 25 units, indicated for the treatment of multiple disorders, diseases or medical states. NDC # 0006-7628-66.

Recall #D-118-8.

CODE LOT NUMBERS

1ml vials: Lots #'s 0307E (EXP. 1/00) and 0909E (EXP. 1/00) 2ml vials (distributed only internationally): Lot 0301B(EXP 3/98) Lot 0734B(EXP 5/98) Lot 0772B(EXP 7/98) Lot 0451E(EXP 6/99) Lot 1086D(EXP 6/99) Lot 1087D(EXP 6/99) Lot 0237B(EXP 2/98) Lot 0238B(EXP 2/98) Lot 1137D(EXP 6/99) Lot 0450E(EXP 7/99) Lot 0435E(EXP 8/99) Lot 0446E(EXP 3/00) Lot 0448E(EXP 3/00) Lot 0617E(EXP 4/00) Lot 1096E(EXP 9/00).

MANUFACTURER

Merck Manufacturing Division, Division of Merck & Company, Inc., West Point, Pennsylvania.

RECALLED BY

Manufacturer, by letter on January 21, 1998. Firm-initiated recall ongoing.DISTRIBUTION Nationwide and international.

QUANTITY

Approximately 2,500 1-ml vials and an undetermined amount of 2-ml vials remained on market at time of recall initiation.

REASON Precipitate/degradation.

 

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.