FDAnews Drug Daily Bulletin

Metal Contamination Concerns Land Tower Laboratories Form 483

Aug. 16, 2012
Tower Laboratories, a contract manufacturer of OTC drugs, has received an FDA Form 483 for failure to fully investigate potential metal contamination of raw materials and finished products. Upon confirming metal contamination in six drums of aspirin raw material, the quality control unit at Tower’s Montague, Mich., manufacturing facility continued to use the tainted material in the blending process — but not during the compression process — until all drums were depleted, the form states. No “material complaint” was issued on the contamination per company protocol.
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