A counterfeit version of Botox was found in the United States, the U.S. Food and Drug Administration (FDA) said in a safety notification dated April 16, 2015. The agency warned that the bogus products may have been sold to doctors’ offices and medical clinics across the country. An unlicensed supplier who is unauthorized to distribute drug products in the US sold the counterfeit product. Continue reading
Drug maker GlaxoSmithKline (GSK) has announced a voluntary recall for the remaining doses of its 2014-2015 Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes (PFS) flu vaccine. The company discovered a reduction in the vaccine’s potency that may reduce the vaccine’s effectiveness.
Glaxo notified the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) about the recall and the recall has been posted by the two agencies and by the company. Thirteen lots of the vaccine are affected by the recall: 2B472, 379MY, 42N4L, 5AZ7H, 9A3ZM, ZS95Z, A2PK7, AR57J, DR4GF, YF5DT, F45C5, T3J4S, and XP4J2. GSK has sent a letter to customers who purchased Flulaval Quadrivalent PFS with directions for returning any unused vaccine from these lots. Continue reading
A school bus filled with 22 children hit a truck in Queens, leaving four people seriously injured. According to New York Daily News, the Penske box truck was headed southbound on Clearview Expressway when it was struck by the school bus on Hillside Ave. near Hollis Court Blvd. In Jamaica Estates. After being hit the by school bus, the truck jumped the curb and slammed into a sidewalk fruit market.
The truck hit a 34-year-old woman and three other pedestrians before hitting the product stand. Witnesses said the awning collapsed, causing fruits and vegetables to fly everywhere. The injured pedestrians were taken to Jamaica Hospital and Long Island Jewish Medical Center. Officials said the injuries were serious, but non-life threatening. The first woman hit suffered a critical injury, but was stabilized by doctors at Jamaica Hospital. Continue reading
According to an April 16, 2015 recall alert posted on the U.S. Consumer Products Safety Commission (CPSC) website, Toro has recalled its walk behind power mower because the wrong blade driver was installed during assembly. This error can result in the blade breaking and lead to an injury, the alert states. Customers affected by the recall should stop using the mowers and contact Toro for a free repair. Continue reading
OriGen Biomedical recalled one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters, according to a recall alert posted on the U.S. Food and Drug Administration’s (FDA’s) website. The devices were recalled due to the risk of the clear extension tube separating from the hub in which it is inserted. Intervention may be needed to prevent permanent impairment or damage if this occurs. The recall affects lot N18549, which expires 09/2018. OriGen knows of at least one product failure, which is associated with a serious adverse event that led to a serious patient injury, the recall indicated. Continue reading
On Tuesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced that Beech-Nut Nutrition is recalling approximately 1,920 pounds of baby food products that may be contaminated with small pieces of glass.
The recalled baby food was produced on December 12, 2014. The following product is subject to recall:
- 4-oz. glass jars containing “Stage 2 Beech-Nut CLASSICS sweet potato & chicken”
An advocacy group for 9/11 responders and clean-up workers, Citizens for the Extension of the James Zadroga Act, has released a video, urging Congress to renew the James Zadroga 9/11 Health and Compensation Act. The Zadroga Act provides treatment and compensation for those who were injured or became ill after exposure to toxins in the aftermath of the 9/11 World Trade Center terrorist attacks.
The World Trade Center Health Program and the September 11th Victim Compensation Fund— key provisions of the act—will expire in October 2015 and October 2016, respectively, unless the Zadroga Act is renewed. U.S. Senator Kirsten Gillibrand is leading the effort for the Zadroga Act renewal. Gillibrand was a sponsor of the original legislation in 2010. Continue reading
The Food and Drug Administration (FDA) is facing criticism of its regulation of dietary supplements containing a dangerous stimulant. The stimulant is BMPEA, a chemical nearly identical to amphetamine. BPMEA is added to weight-loss and workout products to enhance their effect.
BPMEA has never been tested for safety and effectiveness in humans and is not a permissible ingredient in dietary supplements. The FDA was the first agency to suspect that BMPEA had been added to supplements that listed the little-known plant acacia rigidula among the ingredients. Experts say that plant listings like this are often an indication that the manufacturer is trying to disguise a chemical additive as a natural botanical extract, the New York Times reports. Continue reading
The U.S. Food and Drug Administration (FDA) is warning that Tri-Methyl Xtreme, a muscle-building supplement sold by Las Vegas company Extreme Products Group, has been linked to liver damage. According to Associated Press, the supplement was linked to three reported injuries in California, New Jersey and Utah. The FDA began investigating the product following these reports.
Tri-Methyl Xtreme claims to contain anabolic steroids, although it is sold as a dietary supplement. Dr. Charles Lee of the FDA drug center’s office of compliance said that anabolic steroids “may have a range of serious adverse effects on many organ systems, and the damage may be irreversible,” according to Wall Street Journal. The FDA warned that these chemicals can also negatively impact cholesterol levels, increase the risk of heart attack and stroke, cause masculinity in women and lead to testicle shrinkage. Continue reading