TFDA orders two brands of antibiotics recalled

Taipei, June 6 (CNA) Two brands of antibiotics are being recalled after failing a visual inspection and inaccurately presented data, Taiwan Food and Drug Administration (TFDA) reported on Thursday.

A total of 4,590 bottles of Azithrom Powder for Oral Suspension from Anxo Pharmaceutical Co., Ltd. with batch number 221123 have been ordered recalled by June 13, following tip-offs about apparent caked lumps inside the powder, according to TFDA recall information confirmed to reporters by FDA Deputy Director-General Wang Der-yuan (王德原).

The antibiotic, which has azithromycin dihydrate as its main ingredient, is usually used to treat upper and lower respiratory tract diseases, sexually transmitted diseases, skin, soft tissues and otitis media infections.

Last year, 52,160 bottles of the brand were used under the National Health Insurance (NHI) program, accounting for 53.6 percent of the market, Wang said, adding that the recall will not affect normal antibiotic supply.

Meanwhile, Long Life Nutraceutical International Co., Ltd. was also instructed to recall 2,020 vials of Colistar Lyo Inj. that it commissioned Genovior Biotech Corp. to manufacture after inaccurately presented biaossay data was found in written and computer form, Wang said.

The 2,020 vials of Colistar Lyo Inj. with batch number 900060AA001 must be fully recalled by July 24, according to the recall information.

The antibiotic injection contains the key ingredient sterile sodium colistin methanesulfonate, which is restricted for treating severe infections caused by gram-negative bacteria that cannot be cured with common types of antibiotics, TFDA data showed.

Only 17 vials were used under the NHI scheme last year, Wang said.