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DURAMED CLASS II RECALL FOR MISLABELED CONJUGATED ESTROGENS

Executive Summary

DURAMED CLASS II RECALL FOR MISLABELED CONJUGATED ESTROGENS covers 838 bottles of 100s shipped by Rugby Labs. The recall of Duramed's 1.25 mg conjugated estrogens (lot no. 6493), initiated on Nov. 12, is being conducted by Rugby. A portion of the lot was mislabeled .625 mg conjugated estrogens. In publishing pharmaceutical related actions from FDA's Dec. 3 "Enforcement Report," the "The Pink Sheet" incorrectly listed the Duramed recall as a Class I ("The Pink Sheet" Dec. 8, T&G-11).
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