Monday, September 22, 2014

An Illinois  compounding pharmacy is recalling a long list of drugs shipped to medical offices and patients in six states because the drugs-- which are inhaled, injected or used as eye drops-- may not be sterile.

Martin Avenue Pharmacy is recalling its compounded sterile preparations because patients who use them may be at risk of infection. There have not yet been any reports of illness or injury, according to the company. The company has stopped production of sterile products "until further notice."

The list is long. Find it in PDF format here:

Compounding Pharmacy Recalls Potentially Contaminated Drug Products

Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile. Pharmacy Creations no longer uses Front Range, Inc. for testing of any kind for any of its formulations.

Read more here:

Dried fish shipped nationwide recalled due to potential for botulism

A Brooklyn-based importer is recalling certain packages of its dried vobla -- a type of fish -- because they may be contaminated with the spores that cause botulism.

Tuesday, September 16, 2014

Regeneca Expands Recall of RegeneSlim Dietary Supplement

Regeneca Worldwide is expanding its voluntarily nationwide recall of RenegeSlim appetite control dietary supplement because FDA analysis confirmed the presence of DMAA. DMAA is 1,3-dimethylamylamind, methylhexanamine, or geranium extract. It can narrow blood vessels and arteries, which can cause a rise in blood pressure that increases the risk of heart attack.

FDA takes action against Georgia dietary supplement manufacturer

A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber. 
BioAnue’s products were sold as supplements but were unapproved new drugs because they were marketed as treatments for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes, without approval from the FDA, according to the court order. The order was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia.   
The defendants did not take appropriate corrective action in response to a FDA warning letter issued on Feb. 9, 2012, involving the marketing of the firm’s dietary supplements as unapproved new drugs. A follow-up FDA inspection in August 2012 revealed that BioAnue was also manufacturing products that were not in compliance with FDA’s current good manufacturing practice requirements for dietary supplements.
The permanent injunction prohibits the manufacture or distribution of products until the defendants hire independent experts to assist in bringing the firm’s manufacturing practices and labeling into compliance with the law.
District Judge Marc T. Treadwell said, in the court order, that the government was able to provide evidence that the defendants sold unapproved new drugs and failed to follow FDA’s current good manufacturing practice regulations for dietary supplements.
“The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.”
The defendants’ products include: TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA warns of dangerous drugs in weight loss supplements: Tainted dietary supplements

The Food and Drug Administration is warning consumers that three weight loss supplements sold online and in some retail stores contain dangerous pharmaceutical ingredients hidden from consumers, and should be thrown away.

The supplements-- called LX1, Mezo, and Best Line Suplemento Alimenticio-- are part of a growing trend of dietary supplements sold for weight loss and sexual enhancement, usually advertised as "herbal" or "all natural," which really contain pharmaceutical ingredients.

According to FDA testing, LX1 contains undeclared DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract. DMAA, an amphetamine derivative, is an illegal ingredient often sold in products that claim to boost energy, burn fat or build muscle. It can "can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack,"according to the FDA.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use LX1, a product promoted and sold for weight loss on various websites, including Dr. Skin Secretsdisclaimer icon, and possibly in some retail stores.LX1 Contains Hidden Drug Ingredient
FDA laboratory analysis confirmed that LX1 contains undeclared DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract. Ingestion of DMAA can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.
Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.”  FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories.