phosLo — Class II drug recall D-1343-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-05-28, distributed in PA. Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle.
| Recall number | D-1343-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-08-13 |
| Distributed | PA |
| Quantity | 14,496 bottles |
| Reason classes | chemical contamination |
| NDC | 00781-2081-02 |
| Lot numbers | 08/18, 13064, 13065, 13066 |
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 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..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1343-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.