April 2014 FDA Recall Drug by Fresenius Medical Care Holdings, Inc.
D-1343-2014 - Cross Contamination with Other Products

This Class II drug recall was voluntarily initiated by Fresenius Medical Care Holdings, Inc. on April 14, 2014 for the product Drug. The FDA reported the reason for recall as cross contamination with other products. The product was distributed in PA and the recall is currently terminated.

Recall Number: D-1343-2014

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..
Initiated
04-14-2014
Reported
05-28-2014
Quantity
14,496 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67995
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-13-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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