Category Archives: FDA

Top selling Amazon “EzriCare” eyedrops banned from importation to the US.

February 3, 2023 By in Attorney, CDC, FDA, Import Export Attorney Tags: , , , , , , , Leave a comment
a woman using an eye drops
Photo by Karolina Grabowska on Pexels.com

According to the Food and Drug Administration (FDA) announcement today (Thursday, February 2, 2023); imports of products made by Indian healthcare company, Global Pharma Healthcare Private Limited and sold under the brand names “EzriCare” or “Delsam Pharma” are restricted from importation to the US.

The import ban is a result of a recall of the eye drops due to violations of manufacturing regulations by the manufacturer, lack of microbial testing and concerns over tamper-evident packaging. The violations have led to a potential bacterial contamination that increases the risk of eye infections that may result in blindness or even death.

The U.S. Centers for Disease Control and Prevention claims at least 55 people around the US have been impacted by the bacterial contamination. So far one person has died from the infection and 5 of 11 patients with infections in their eyes have lost their vision.

The eye drops are top sellers on Amazon and also available through Walmart. If you or your company are on the FDA “red list”, contact attorney David Hsu by phone/text at anytime, 832-896-6288 or by email at attorney.dave@yahoo.com; dh@gjatradelaw.com.

Nearly half million in counterfeit contacts seized.

November 25, 2021 By in FDA, Notice of Seizure Tags: , , , , Leave a comment
Counterfeit contact lenses, source: CBP.gov

In late October, U.S. Customs and Border Protection (CBP) officers along with the U.S. Food and Drug Administration (FDA) Office of Criminal Investigation special agents and FDA consumer safety officers seized nearly half a million dollars worth of nearly 26,000 pairs of counterfeit contact lenses. Contact lenses are regulated by the FDA and CBP is the enforcement mechanism.

The CBP media release further highlighted the dangers of purchasing counterfeit goods to the American consumer. If you have had your goods seized on suspicion of being counterfeit, contact seizure attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com

Unapproved Juul pods seized by CBP.

April 12, 2021 By in Attorney, FDA, Import Export Attorney Tags: , , , , , , , , Leave a comment
Image of seized Juul pods, source: CBP.gov

According to a U.S. Customs and Border Protections media release, officers in Indianapolis over 10,000 Juul Pods shipped from Ontario, Canada to New York and New Jersey. The shipments were seized because they were misbranded consumer goods imported by an unauthorized agent.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) governs the importation of e-cigarettes and other tobacco products. However, the basis of this seizure was likely under 19 USC 1499(a)(3)(a) unspecified articles and 19 USC 1595(c)(1) merchandise introduced contrary to law because the packages were labeled as an “electrical apparatus”.

If you have had your goods seized and you received a seizure notice alleging violations of 19 USC 1499 and 19 USC 1595, contact David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com.

Unapproved Viagra RX seized.

March 3, 2021 By in Customs Lawyer, FDA, Notice of Seizure, viagra Tags: , , , Leave a comment
Image of seized Viagra pills, source: CBP.gov

According to a U.S. Customs and Border Protection (CBP) media release – CBP officers in Louisville, Kentucky seized over 618 bottles of Viagra containing about 18,540 pills. The Food and Drug Administration (FDA) seized the pills for being misbranded – a violation of the Federal Food, Drug and Cosmetic Act (FDCA).

Since the pills were being imported, they were likely purchased online and may have been produced abroad and seized by the FDA on the basis the pills were from a non-regulated foreign company and may contain da ngerous compounds, with different ingredients and poor quality control.

I-f you have had your goods seized by Customs, contact seizure attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com.

Counterfeit COVID test kits, medication and facemasks seized by CBP.

October 18, 2020 By in covid-19, Emergency Use Authorization, EUA, FDA, Notice of Seizure Tags: , , , , , , , Leave a comment

According to a U.S. Customs and Border Protection (CBP) media release, CBP officers in Baltimore and Pittsburgh seized shipments of unapproved or counterfeit COVID-19 medications, facemasks and testing kits.

The seizure included more than 58,000 face masks with designs violating trademarks of several designer consumer brands, professional sports teams, car manufacturers and cartoon characters. See below for a sampling of the various designs violating protected marks.

In addition to the facemasks, CBP officers also seized products claiming to be medication for COVID infected persons and more than 130 test kits not on the Emergency Use Authorization (EUA) list. Due to the non-compliance with FDA rules, the goods were seized and deemed inadmissible.

If you have had your good seized by Customs for violating FDA rules, contact seizure attorney David Hsu by phone/text anytime at 832-896-6288 or by email at attorney.dave@yahoo.com.

Images of seized test kits, source: CBP.gov

Syringes with unapproved drugs seized by FDA.

October 17, 2020 By in FDA, Food and Drug Administration, Notice of Seizure, pharmaceutical drugs, Uncategorized Tags: , , , , Leave a comment
Seized syringes: source: CBP.gov

According to a U.S. Customs and Border Protection media release – officers seized a shipment of pre-filled syringes containing 200 Sodium Hyaluronate from Seoul, South Korea. Sodium Hyaluronate is used to treat osteoarthritis and seized for violation of the Food, Drug and Cosmetic Act (FDCA) prohibiting the importation of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.

The FDA Office of Criminal Investigation seized the shipment that would be worth $10,666 if authentic. Typical FDA seizures are due to unapproved prescriptions containing manufactured using incorrect or harmful ingredients.

If you have had your shipment seized by Customs for FDA violations, contact seizure attorney David Hsu by email at attorney.dave@yahoo.com or anytime by phone/text at 832-896-6288.

Unauthorized COVID medicine seized.

August 17, 2020 By in covid-19, FDA, Notice of Seizure Tags: , , , , , Leave a comment

COVID-19 treatment bills – source: CBP.gov

Since July, U.S. Customs and Border Protection (CBP) Officers in Seattle have seized 8 shipments totaling over 2,400 pills of unauthorized influenza treatments for COVID-19. Working with the FDA, CBP prevents unauthorized medicines that may mislead consumers by falsely claiming to treat or prevent diseases.

If you have had your goods seized by Customs and want to explore your options contact David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com.

Prescription medication seized by CBP.

August 9, 2020 By in Customs Lawyer, FDA, pharmaceutical drugs, U.S. Customs and Border Protection Tags: , , , Leave a comment
Image of seized medication, source: CBP.gov

U.S. Customs and Border Protection (CBP) officers in Indianapolis seized multiple shipments of Zolpidem, 10 milligram tablets, a schedule IV controlled substance used as a sedative.

The packages were sent from the United Kingdom and headed to separate addresses in the US. The shipments were arriving from the United Kingdom and were all headed to separate addresses. The shipper hid the Zolpidem in coffee tins.

If you have had your goods seized by Customs and want to explore your options, contact David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com.

Unapproved and counterfeit goods seized by Customs.

August 8, 2020 By in corona virus, covid-19, FDA Tags: , , , , , Leave a comment
Counterfeit COVID medications, source: CBP.gov

U.S. Customs and Border Protection (CBP) officers in Baltimore seized unapproved COVID-19 medications, facemasks and test kits earlier this month.

The seized goods included 1,200 pills of COVID medicines, including Hydroxycholorquine sulfate, 2,000 pills of various anti-COVID drugs not approved by the FDA, and 100 unapproved test kids. Besides unapproved drugs and test kits, CBP also seized face masks with registered trademarked logos such as Nike, Adidas, Fila and even Manchester City football club.

This most recent seizure is just one of many seizures of test kits, diagnostic kits, respirators and even unapproved face masks.

If your goods have been seized by Customs, contact customs attorney David Hsu at 832-896-6288 or by email at attorney.dave@yahoo.com.

CBP seizes 15,000+ Xanax pills destined for Texas.

August 7, 2020 By in FDA, pharmaceutical drugs Tags: , , , , , , , , Leave a comment
Seized Xanax pills, source: CBP.gov

U.S. Customs and Border Protection (CBP) officers in Cincinnati seized a shipment of approximately 15,750 Xanax pills June 30th. The shipment was from Britain and opened for further examination due to x-ray anomalies as a result of a foil lined box. Upon opening the box, they found 63 bottles marked “Xanax XR 2mg”, if authentic, the Xanax pills would have totaled over $230,000.

As you are aware, Xanax is used for the treatment of anxiety and classified as a Schedule IV controlled substance and cannot be shipped to the US without a prescription from a physician. The shipment was addressed to a residence in Texas.

Author’s notes – usually there’s something to do for a seizure from Customs; however in situations where a schedule 4 controlled substance is shipped to an individual in a box meant to hide the contents from x-ray scanners and mailed without a physician’s prescription – there’s probably not much I can do to assist.

The lesson here is to not even take the risk to try and import drugs, especially controlled substances to the US. CBP may refer your case to Homeland Security Investigations and will likely also issue you a civil penalty.

Have you had your good seized? Contact David Hsu by phone/text at 832-896-6288 or email at attorney.dave@yahoo.com for a free consultation.