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Recall Observatory FDA recall evidence

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

D-1343-2014

April 14, 2014

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 67995
Status
Terminated
Classification
Class II
Quantity
14,496 bottles
Official record key
drug-enforcement:D-1343-2014

Official wording

Reason: 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..

Code information: Lot # 13064, 13065, 13066; Exp. 08/18

Distribution pattern: PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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..