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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 20, 1998

PRODUCT
Cyanocobalamin Injection, USP, 1,000 mcg/mL, in 1 mL multiple dose vials, 25 vials per carton, Rx indicated for Vitamin B12 deficiencies. NDC #0469-1044-25.

Recall #D-133-8.

CODE
Lot numbers: 370007, 370080, 370139, 370187, 370305, 370338, 370396, 370489, 370570, 382027.

MANUFACTURER
FUJISAWA USA, Inc., Grand Island, New York.

RECALLED BY
Manufacturer, by letter dated April 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Egypt, Saudi Arabia, Canada.

QUANTITY
1,651,450 units (66,058 cartons) were distributed.

REASON
Unapproved change in raw material.

 

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.