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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67995

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 14, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fresenius Medical Care Holdings, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1343-2014
Recall number
D-1343-2014
Initiated
April 14, 2014
Classification
Class II
Status
Terminated
Quantity
14,496 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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..

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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..

Code information

Lot # 13064, 13065, 13066; Exp. 08/18

Distribution pattern

PA