FDA recalls anti-bacterial medicine
MANILA, Philippines - The Food and Drug Administration (FDA) has ordered the recall of a batch of an anti-bacterial medication after it was found lacking in potency.
Citing results of the FDA’s laboratory analysis, FDA director general Kenneth Hartigan-Go said “the label claim of Cefuroxime 750 mg Powder for Injection (Zurenix) batch 9600 is below the required potency.â€
Go also warned that this specific batch presents “a safety risk and adverse health consequences as it potentially exposes patients to suboptimal dose of Cefuroxime therapy.â€
The product is manufactured by Flamingo Pharmaceuticals Ltd-India and imported by Pasteur Pharmaceuticals Sales.
The FDA has ordered Pasteur Pharmaceuticals to discontinue the distribution of the affected batch of the product.
All retail outlets are also advised to stop selling the affected batch of the product to consumers, while health care professionals are advised against its use.
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