FDA: Firm recalls ferrous sulfate products

Consumers were advised Monday against buying a batch of ferrous sulfate product being voluntarily recalled by its manufacturer.

 

The Food and Drug Administration said Monday Dann's Aid Laboratories Inc. is voluntary recalling a batch of "La Rosa Vino de Quina" 2mg/mL solution.

 

"The Product lot was found to contain Thiamine Hydrochloride as its Active Pharmaceutical Ingredients (API) whereas the approved API in its Certificate of Products Registration (CPR) is Ferrous Sulfate (as heptahydrate)," it said.

 

It said the impacted lot number is 130205, manufactured in February 2013 and with expiry date in February 2015.

 

FDA said the affected product lot "presents safety risk and potential health consequences."

 

The FDA said the product is used for nutritional anemia and loss of appetite, and in cases of convalescence after illness and chronic debilitating condition by increasing the appetite.

 

It added the product is packed in a clear glass bottle containing 320mL solution.

 

FDA instructed distributors, retailers, hospitals, pharmacies, or clinics that have the affected lot "to discontinue further distribution, sale and use."

 

Also, it advised consumers not to purchase or use the affected product lot.

 

The FDA likewise instructed field officers to monitor the availability of the product lot in the market.

 

Meanwhile, the FDA said consumers may contact Dann's Aid Laboratories Inc. at telephone number +63 44 292-1485 or email the DFA at info@fda.gov.ph for additional information.

 

Adverse reactions can be reported immediately to www.fda.gov.ph. —Joel Locsin/KG, GMA News