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Class II: temporary or reversible health riskTerminated

Fresenius Medical Care Holdings phosLo Recall

phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for F…

Fresenius Medical Care Holdings, Inc. · Waltham, MA

Risk level
Class II
Reported by FDA
May 28, 2014
Recall ID
D-1343-2014
Check your lot numberHow we source this data

Summary

Fresenius Medical Care Holdings recalled phosLo starting Apr 14, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1343-2014 on May 28, 2014. 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.. Status: Terminated.

Why it was recalled

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..

Product 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

Lot numbers, UPCs & expiration codes

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

Where it was sold

PA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1343-2014
Classification
Class II
Status
Terminated
Recall initiated
Apr 14, 2014
FDA report date
May 28, 2014
Quantity
14,496 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Medical Care Holdings, Inc.

Original FDA data

Every field from FDA enforcement report D-1343-2014, exactly as published.

Show all FDA fields
City
Waltham
State
MA
Status
Terminated
Country
United States
Event ID
67995
Address
920 Winter St
Code information
Lot # 13064, 13065, 13066; Exp. 08/18
Postal code
02451-1521
Report date
May 28, 2014
Product type
Drugs
Recall number
D-1343-2014
Classification
Class II
Recalling firm
Fresenius Medical Care Holdings, Inc.
Product quantity
14,496 bottles
Termination date
Aug 13, 2015
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..
Voluntary / mandated
Voluntary: Firm initiated
Product 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
Distribution pattern
PA
Recall initiation date
Apr 14, 2014
Initial firm notification
Letter
Center classification date
May 21, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1343-2014, published May 28, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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