Class II
Terminated
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
This recall has been terminated (originally issued May 28, 2014).
- Recall Initiated
- April 14, 2014
- Posted
- May 28, 2014
- Recall Number
- D-1343-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,496 bottles
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot # 13064, 13065, 13066; Exp. 08/18
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