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FDA Recalls & Court Actions: June 20, 1990

Executive Summary

CLASS II -- MUROMONAB-CD3 ORTHOCLONE OKT3 STERILE SOLUTION 5 mg (1 mg/1ml), for IV use only. Lot numbers: 19B007 EXP 11/89, 19D014 EXP 12/89, 68K111 EXP 7/89, 68L116 EXP 8/89, 68N129 EXP 9/89. Manufacturer: Ortho Pharmaceutical Corporation, Biotech Division, Raritan, New Jersey. Recalled by: Manufacturer, by telephone between Aug. 7, 1989 and Dec. 18, 1989. Firm-initiated recall complete. Distribution: Nationwide, Japan, Mexico, Switzerland. Firm estimates none remains on market. Reason: Product failed to maintain stability throughout the approved dating period.

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