phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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..
What 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
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- NDC code
- 0781-2081-02
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1343-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.