FDA stops sale, use of anti-bacteria drug

THE Food and Drug Administration (FDA) reiterated its call to all distributors, hospitals, retailers and pharmacies to discontinue further distribution, sale and use of a specific anti-bacterial drug as this may cause possible health risks.

This, after the PhilRx Pharma has recalled from the market its Philtam brand Piperacillin + Tazobactam 4g/500-mg powder for injection under batch no. 773150402 with April 2017 expiry date due to mislabeling.

“The error which shows the dosage strength of Tazobactam as 500-g instead of 500-mg can be seen under formulations on the vial, on the side panels of individual box and of the outer box which contains the 10 individuals boxes,” the FDA said.

Philtam is used for documented multidrug resistant gram-negative infections due to organisms proven or suspected to be a susceptible to piperacillin-tazobactam except CNS infections.

According to the FDA, the drug product is packed in type I glass vial in a plastic tray enclosed in an individual box. An outer box contains 10 individual boxes of the drug product.

“The affected product batches present safety risks due to mislabeling thus distributors, hospiDAVAO tals, and pharmacies that have such product are instructed to discontinue the distribution, sale and use,” the FDA said.

All consumers are also advised to be keen observant in purchasing product and not to purchase or use the affected product. The consumers may contact PhilRx Pharma Inc. through +632 655-5492 or email info@fda.gov.ph for more information.

The FDA officers of the Field Regulatory Operations Office (FROO) are ordered to monitor the availability of the product lot in the market and appropriately seal discovered stocks of the affected lot of the product.

The concerned agency is advised to instruct other concerned establishments to give back the sealed stocks to the Marketing Authorization Holder (MAH) for proper destruction to be witnessed by an appropriate FDA representative. ICT