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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 27, 1999

PRODUCT
Rocephin Sterile Powder for Injection, in 6 ml vials (Ceftriaxone Sodium), 250 mg, Rx broad-spectrum antibiotic. NDC #0004-1962-01. Recall #D-072-9.

CODE
Lot #0637 EXP 4/01.

MANUFACTURER
Hoffman-La Roche, Inc., Totowa Antibiotic Focused Facility, Totowa, New Jersey.

RECALLED BY
Hoffman-La Roche, Inc., Nutley, New Jersey, by telephone on July 23 & 24, 1998, followed by letter sent on July 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
55,700 vials were distributed.

REASON
Label mix-up - Some 250 mg units were labeled as 500 mg units.

 

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.