FDA recalls IV solution

photo from fda.gov.ph

MANILA, Philippines—The Food and Drug Administration (FDA) has directed all pharmacies and healthcare professionals to discontinue selling 8.4% Sodium Bicarbonate Solution for IV infusion manufactured by German pharmaceutical company B. Braun Melsungen AG, which made a voluntary recall of the product with batch numbers 131558021, 124638022 and 121148021.

“The reason for the recall was due to aluminum salt precipitation in the solution caused by the fluctuation in the quality of bromobutyl stopper, which resulted in the leaching of aluminum compounds,” the FDA said in an advisory.

The product is a prescription drug registered with the FDA. It is used in the treatment of metabolic acidosis arising from various disorders such as diabetic coma, diarrhea, kidney disturbances and shock, according to the agency.

The FDA also ordered the recall of all products manufactured by a pharmaceutical firm based in Valenzuela City due to “poor compliance” with good manufacturing practice.

In the advisory, the FDA warned the public against purchasing products manufactured by Compact Pharmaceuticals Corp. from January 2012 up to the present, saying these posed a risk to safety and health.

Critical, major

The FDA, however, did not describe the products and Compact’s website did not list what it produced.

The FDA said its regional field inspectors noted “critical and major” deficiencies in the firm’s manufacturing facility and poor compliance with good manufacturing practice.

“[These] indicate there is no assurance the manufactured products are of good quality… the affected products present a safety risk and potential adverse health consequences,” said the FDA.

It directed the firm to stop manufacturing its products and its distributors to discontinue selling the products.

“All drug retail outlets are ordered to discontinue offering these products for sale [and] all consumers are advised not to purchase or use the affected products,” said the FDA.