FDA Drug recall D-1343-2014
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 024…
- FDA Drug
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 024… by Fresenius Medical Care Holdings, citing 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 identifi….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1343-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-14 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | PA |
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
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..
Identifiers
| code_info | Lot # 13064, 13065, 13066; Exp. 08/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1343-2014%22
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