FDA is publishing its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections in an effort to ensure the quality and safety of globally produced products.
H&C Food Inc of Brooklyn, NY is recalling the Frozen Fuzhou Fish Balls and the Fish Balls, because they may contain undeclared wheat, pork, egg, and crustacean. People who have an allergy or severe sensitivity to wheat, pork, egg and crustacean run the risk of serious or life-threatening allergic reaction if they consume these products.
La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos
FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles
Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis […]
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants […]
FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.
HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia […]
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.
New York State Agriculture Commissioner Richard A. Ball today alerted consumers that the “Lily Bulb” product (photo attached) distributed by Allied Imports Inc. of 267 52nd Street, Brooklyn, NY 11220 was found to contain sulfites, which are not declared on the product label. People who have severe sensitivity to sulfites may run the risk of […]
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).
Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.
FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales
King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible microbial contamination.
A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.