FDA recall D-1343-2014

Fresenius Medical Care Holdings, Inc. · Class II · drug

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

Reason for recall

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..

Distribution

PA

Key facts

Status
Terminated
Initiation date
2014-04-14
Report date
2014-05-28
Termination date
2015-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1343-2014