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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 12, 1998

PRODUCT
Cyanocobalamin Injection, USP, 1000 mcg/mL, in 30 mL multiple dose vials, Rx, sterile solution of injectable vitamin B-12, under the following labels: Steris Label: NDC 0402-0091-30 Moore Medical Label: NDC 0839-5661-36 Clint Pharmaceuticals Label: NDC 55553-091-30 United Research Laboratories Label: NDC 0677-0323-23 Zenith Goldline Label: NDC 0182-0202-66 Besse Medical Label: NDC 53614-091-30 Schein Canada Label: DIN 02229972 Keene Pharmaceuticals: NDC 0588-5215-90 Schein USA Label: NDC 0364-6651-56 The product is also packaged for export under the CYTEX LABEL. Recall #D-215-8.

CODE
Lot Number 97D690, expires 3/2000 (applies to all labels)

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

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

DISTRIBUTION
Nationwide and Canada.

QUANTITY
62,635 vials were distributed.

REASON
Manufacturing deviations (unapproved potency adjustment).

 

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.