Archives for March 2015

Recall of Ultra ZX Since It Contains Undeclared Sibutramine and Phenolphthalein

FOR IMMEDIATE RELEASE — March 10, 2015 — Miami, Florida — UltraZx, Labs, L.L.C. is voluntarily recalling “UltraZx” weight loss supplements. This product has been found to contain undeclared Sibutramine and phenolphthalein.

FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir Harvoni or Sovaldi in combination with another Direct Acting Antiviral drug

On March 24, 2015, FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (active ingredients ledipasvir and sofosbuvir) or with Sovaldi (active ingredient sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. We are adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. We are recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (active ingredient simeprevir), with amiodarone. Patients should not stop taking any of their medicines without first talking to their health care professionals.

FDA Launches Drug Shortages Mobile App

The U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

Non-FDA Approved Hormone Therapies on the Rise

Use of potentially risky, non-FDA approved hormone therapies may soon be as common as use of FDA-approved hormone therapies, according to a study by University of Virginia gynecology researcher JoAnn Pinkerton. Between 28 and 68 percent of menopausal hormone users take “compounded therapies,” hormone formulations that have been compounded by pharmacists, but whose precise ingredients have not been monitored, or approved, by the FDA, the study reports.

FDA proposal would allow drugmakers to rebut warnings

The Food and Drug Administration is proposing to allow pharmaceutical companies to contradict official safety warnings in sales presentations to customers.

While an FDA warning about a drug’s dangers can scare off buyers, the new proposal would allow the companies to present customers with information that undermines official warnings as long as it comes from a peer-reviewed journal article.

Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial Due to a Lack of Sterility Assurance

Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10). Heritage has initiated this voluntary recall of Colistimethate for Injection, USP, 150 mg Single-Dose vial and Rifampin for Injection USP, 600 mg Single-Dose vial to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility.

FDA issues new draft documents related to compounding of human drugs

Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states.

Our XLTC Isolators

One of the most recent additions to our product line are our XLTC Isolators that incorporate a completely segmented, large and aseptic area for incoming product to be properly disinfected.