FDA recalls antibiotic manufactured in China
photo from fda.gov.ph
MANILA,—A brand of antibiotic drug manufactured in China has been recalled from the market after the Food and Drug Administration found it posing “safety risk and adverse heath consequences.”
In an advisory posted on its website, the FDA warned the public against buying Amoxicillin (Ambimox) 500 mg capsule with batch number 130216 and registration number DE- XY40623.
The drug was manufactured by CSPC Zhongnuo Pharmaceutical Co., Ltd., a Chinese company, and imported and distributed by AMB HK Enterprises.
“Based on the result of laboratory analysis conducted by FDA, it was found that the label claim of Amoxicillin (Ambimox) 500 capsule is below the required potency,” said the advisory, which was signed by Kenneth Hartigan-Go, FDA acting director general.
Since “it provides only a sub-optimal dose of amoxicillin,” the FDA finds the sale of the product as a risk to the safety and health of the public.
The FDA likewise ordered all drug retail outlets to discontinue selling the product and warned doctors against prescribing the drug.
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