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
Reported: May 28, 2014 Initiated: April 14, 2014 #D-1343-2014
Product Description
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..
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 14,496 bottles
- Distribution
- PA
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 14,496 bottles.
Why was this product recalled? ▼
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..
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 28, 2014. Severity: Moderate. Recall number: D-1343-2014.
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