FDA orders faulty batch of anti-bacterial cefuroxime off shelves

The Food and Drug Administration has ordered a batch of Cefuroxime, a medication for bacterial infections, recalled from the market.

The FDA, in Advisory 2014-020, advised the public on Monday to look out for Cefuroxime 750mg powder for injection products with batch number 9600.

It said the batch was manufactured by Flamingo Pharmaceuticals Ltd.-India and imported by Pasteur Pharmaceuticals Sales.

"Based on the result of laboratory analysis conducted by FDA, it was found that the label claim of Cefuroxime 750 mg Powder for Injection (Zurenix) batch 9600 is below the required potency," it said.

"(This) specific batch of Cefuroxime 750mg Powder for Injection presents a safety risk and adverse health consequences as it potentially exposes patients to a suboptimal dose of cefuroxime therapy," it added.

Included in the list of recalled products are:

• DRP-282, Zurenix
• DRP-282-02, Eurimax
• DRP-282-03, Cefunor
• DRP-954, Zurenix WFI
• DRP-954-01, Baktime WFI
• DRP-954-02, Hiquacef
• DRP-954-03, Cervin
• DRP-954-04, Cefura
• DRP-954-05, Rezafil WFI

The FDA ordered Pasteur Pharmaceutical Sales to discontinue the distribution of the affected batch.

It also instructed retail outlets "to discontinue selling or offering for sale the said batch of the products to the consumers."

"Health-care professionals are advised not to use the particular batch of the product," it added.

The US National Library of Medicine's MedlinePlus site said cefuroxime is used to treat certain infections like bronchitis, gonorrhea, Lyme disease, and infections of the ears, throat, sinuses, urinary tract, and skin.

"Cefuroxime is in a class of medications called cephalosporin antibiotics. It works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, or other viral infections," it added. — Joel Locsin/JDS, GMA News