China-Made Antibiotic Yanked Off the Shelf

China-Made Antibiotic Yanked Off the Shelf

 

FDA cites ‘safety risks, adverse health consequences’

It never stops – this recurring incidence of either fake, knock-offs or imitation, sub-standard, and. therefore, dangerous drugs from China.

But then again why even wonder when that country churns out fake high-end leather goods, watches, other fashion accessories, cell phones, perfumes, cosmetic products and who knows what else?

There was even this story of a Chinese meat-processing facility that magically turns meat from pork into “beef” allegedly using industrial dyes and other potentially dangerous chemicals.

But fabricating what are supposedly life-saving drugs whose safety is not verifiable and. therefore, potentially hazardous to health is definitely a public health issue that has to be seriously dealt with.

And so the state food and drug watchdog dutifully sprang into action to yank a Chinese antibiotic off the shelves.

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 health 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.

Ambimox 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,” the advisory signed by acting FDA Director-General Kenneth Hartigan-Go, said.

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.

[pq]The FDA also ordered all drug retail outlets to stop selling the product and warned doctors against prescribing it.[/pq]

 

Earlier, the FDA strongly urged consumers to check labels and packaging. Most counterfeit drugs have labels that are poor replicas of the original. The pills themselves could be irregularly colored or they crumble easily.

Consumers should also buy from drugstores licensed by the FDA and ask for a receipt so they could go back if they were sold suspect drugs.

If they have doubts, consumers can call the FDA at 156-FDA or 8078275, or text 09092090500.

For his part, Health Sec. Enrique Ona has said consumers should check the packaging for information about the manufacturer, date of manufacture, and the lot number.

Ona noted that many drugs were sold in packages containing only the name of the distributor and this was alarming

One comment

  1. Thank you for this article. However, may I take this opportunity to correct the contact numbers indicated therein:

    Consumers are encouraged to report Adverse Drug Reaction or any unwanted reactions after taking any medicine via email report@fda.gov.ph or log in at the FDA website (www.fda.gov.ph) and click the ADR Report button. For more information or clarification about a particular medicine or a drug product, via info@fda.gov.ph OR call telephone no. + 63 2 857 1900 (FDA trunkline) or the Center for Drug Regulation and Research at telephone no. +63 2 857 1990 or Public Assistance, Information, and Receiving (PAIR) at telephone no. +63 2 807 8386 or 857 1975.

    Very truly yours,

    Amy V. Alialy-Arguelles
    Head Executive Assistant
    Food and Drug Administration

Leave a Reply

Your email address will not be published. Required fields are marked *

*