CALCIUM ACETATE Recall D-1343-2014
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
CALCIUM ACETATE Recall D-1343-2014 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm Initiated |
| Recall Number | D-1343-2014 |
| Event ID | 67995 |
| Brand | CALCIUM ACETATE |
| Generic Name | CALCIUM ACETATE |
| Manufacturer | CALCIUM ACETATE |
| Original Package? | 1 |
| Active Substance | CALCIUM ACETATE |
| Drug Route | ORAL |
| Distribution | PA |
| Quantity | 14,496 bottles |
| Recall 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.. |
| Drug Classification | Class II |
| Drug Code Info | 20140528 |
| Product NDC | 0781-2081 0781-2672 |
| Recall Initiation Date | 20140414 |
| Report Date | 20140528 |
| Termination Date | 20150813 |
| Classification Date | 20140521 |
| Address | 920 Winter St Waltham, MA 02451-1521 United States |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | Y882YXF34X |
| Drug Application Number | NDA021160 |
| Structured Product Labeling (SPL ID) | d0d89863-c38a-8774-e053-2a95a90a1723 |
| Structured Product Labeling (SPL Set ID) | 4d5c8c68-2755-4d7c-b689-6c5e50ff1b26 |
| Similar To |