Safety Alerts & Recalls

What does this mean?

This recall for PhosLo (calcium acetate), 667 mg GelCaps from Fresenius Medical Care Holdings, Inc. was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patient does not pose a significant health risk. If you take PhosLo (calcium acetate), 667 mg GelCaps and are concerned, you should speak to your doctor.

Fresenius Recalls Single Lot of PhosLo GelCaps

Fresenius Medical Care Holdings, Inc. and Braintree Laboratories Inc have recalled a single lot of PhosLo GelCap 667 mg. Lot number 1308035 has been recalled because this lot failed the manufacturer routine tests that measure the gelcaps' ability to dissolve.

PhosLo GelCaps contain the active ingredient calcium acetate and are commonly used in the treatment of high phosphate levels in the blood in end stage kidney disease. This recall alert only applies to the single lot of PhosLo (calcium acetate), 667 mg GelCaps. No other calcium acetate products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-10-27
Last Updated: 2010-10-29

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