FDA Alert: Multistate outbreak of fungal meningitis and other infections

Multistate outbreak of fungal meningitis and other infections. FDA provides NECC Customer List. Ameridose recalls all products. This is a summary of the FDA Alerts on fungal meningitis and bacterial contamination in New England Compounding Center (NECC) products and recall of Ameridose products. Bacterial contamination also found in NECC Products. [11-01-2012] The U.S. Food and…

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FDA Alert: Dietary Supplements Recalled Because of Undeclared Ingredients

  Dietary Supplements Mojo Nights and Mojo Nights for HerFDA Recalls via FDA Website. This is a reprint of an FDA Alert. FDA Alert: Evol Nutrition Associates, Inc./ Red Dawn Issues Voluntary Nationwide Recall of Dietary Supplements Mojo Nights and Mojo Nights for Her Because of Potential Health Risk FOR IMMEDIATE RELEASE – August 23,…

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FDA Alert: Body Basics Inc. Issues a Voluntary Nationwide Recall of ACTRA-Sx 500 Capsules, Lot 008-A, due to Potential Health Risks

This is a reprint of an FDA press release. FOR IMMEDIATE RELEASE – September 12, 2012 – Body Basics Inc. announced today that it is conducting a voluntary nationwide recall of ACTRA-Sx 500 Dietary Supplement Capsules, Lot 008-A, Expiration December 2013. The Company, through independent lab analysis has confirmed the presence of Sildenafil Citrate making…

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FDA Alert: Intestinomicina (contains chloramphenicol) by Laboratorios Lopez: Safety Alert – Contains Drug Ingredient Withdrawn from US

FDA is warning consumers not to purchase or use Intestinomicina, a drug marketed for infectious diarrhea, due to its containing unnaproved and dangerous ingredients.  A quick Google search by PSM turned up several Spanish-language websites offering the drug for sale. This is a reprint of an FDA Alert. AUDIENCE: Consumer, Health Professional ISSUE: FDA is…

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FDA Receives Reports of Fatalities Associated With Undeclared Ingredients

The U.S. Food and Drug Administration has issued an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared prescription drug ingredients that have impacted public safety.

The agency announced it has received reports of “fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome,” in the two months since initially announcing the recall on the product in June.

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Reumofan Plus: Recall – Undeclared Drug Ingredient

Reumofan Plus Alert by The U.S. Food and Drug Administration via Flickr. This is a reprint of the FDA Alert. AUDIENCE: Consumer, Health Professional, Emergency Medicine ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on…

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Counterfeit Version of Teva’s Adderall Purchased On Internet Contains Tramadol and Acetaminophen

This is a reprint of the FDA Alert.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists.

FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

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FDA Alert: Recall of X-Rock for Men Due to Undeclared Active Ingredient

This is a reprint of the FDA alert. XROCK INDUSTRIES, LLC Issues a Voluntary Nationwide Recall of X-ROCK, a Product Marketed as a Dietary Supplement to Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient XROCK INDUSTRIES, an independent distributor of the X-ROCK products, is conducting a user level voluntary recall of certain supplement products sold…

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