drugs Class II Updated 2014-05-28

Fresenius Medical Care Holdings, Inc. recalls phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle,

Recalled Product

phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02

Hazard / Issue

Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..

Issued by

FDA

Affected States: PA
Lot/Code Info: Lot # 13064, 13065, 13066; Exp. 08/18
View official government recall

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