MANILA, Philippines – The Food and Drug Administration (FDA) has recalled from the market several batches of an anti-tuberculosis drug.
In an advisory, the FDA warned the public to refrain from purchasing specific batches of rifampicin (brand name Rifanid).
Rifanid 200 mg/5 ml suspension failed to comply with specifications of physical appearance, the FDA said.
The FDA specifically recalled from the market Rifanid with registration number DR-XY30945; batch number/expiry date C40001/January 2017, and C40002/January 2017.
The product was observed to be “caking” instead of settling slowly and should readily re-disperse upon shaking.
As a result, the FDA said the suspension could not be readily poured from the container.
“The stated batches of Rifanid may be toxic if the suspension is not homogenized before administration to the patient. Some parts will have low potency and other parts will have high doses of the active ingredient,” the FDA said.