FDA Recalls Vanilla Flavor of Nepro HP Renal Nutrition

The Food and Drug Administration (FDA) has recalled one batch of the Nepro HP Renal Nutrition–Vanilla Flavor (Food for Special Medical Purposes) from the market.

According to the FDA Advisory No. 2016-045, Abbott Nutrition is voluntary recalling Nepro HP Renal Nutrition– Vanilla Flavor with Lot Number 57648RA00.

“The products in this batch may have a different color, smell, taste or texture which is inconsistent with other lots of Abbott products,” said the FDA.

The agency clarified that the recall involves only the above identified lot and no other Abbott Nutrition products distributed in the Philippines.

Nepro HP Renal Nutrition is a product for the dietary management of people that are on dialysis.

The FDA pointed out that the difference in feature has yet to manifest any potential adverse health effects to consumers.

“While there is no serious health risks to consumers or patients who consume this product, the public is advised to discontinue using products from this lot as a precautionary measure,” the FDA said.

With the recall order, the FDA said all their Field Regulatory Operations Office (FROO) personnel have been ordered to monitor the presence of the product with the specified lot number in the market.

In addition, retailers and consumers that have purchased affected products are advised to contact Abbott Customer Service Hotline at telephone No. +632 995-1555; or e-mail address:familyties.ph@abbott.com.

In a related development, the FDA is renewing its warning to the public against using the Stem Enhance™ dietary supplement.

Based on FDA Advisory No. 2016-046, the product StemEnhance™ continues to be not registered with the government.

“The safety and health claims of the unregistered StemEnhance™ have not been evaluated by the FDA, hence, the public is warned and advised not to patronize the on-line sale of the this product,” said the FDA.

The advisory is a reiteration of a similar advisory versus StemEnhance™ issued by the FDA last August 14, 2013.

It should be noted that the product claims to be a dietary supplement that “supports the natural release of adult stem cells.”

The product is continuously being promoted, marketed, and sold online, according to the FDA. (PNA) SCS/LSJ/SSC