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Patheon halts Omnicef manufacturing

Executive Summary

Patheon subsidiary CEPH voluntarily suspends production of Abbott's Omnicef (cefdinir) powder for oral suspension at its Puerto Rico manufacturing facility after receiving a warning letter from FDA, company says Sept. 28. The CEPH facility was cited by FDA for "out of specification results" due to fill weight variations, failure to implement corrective actions to assure unit product quality, and failure to act on post-marketing adverse event reports that "stated lack of effectiveness." Abbott and Patheon have sent teams to the facility to ensure that corrective measures are implemented. Patheon is Abbott's only Omnicef supplier, but Abbott says it will be able to supply the oral suspension antibiotic to patients requiring it. Production of Omnicef 300 mg capsules remains unaffected...

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