FDAFDA · Food and drugs·Recall number D-1343-2014
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
Published May 28, 2014 · Recall initiated: April 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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..
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- PA
- Lot
- Lot # 13064, 13065, 13066; Exp. 08/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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