Alert
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.
[...]CRM Laboratories Issues a Voluntary Nationwide Recall Due to Undeclared Active Ingredients
Images courtesy of the FDA This is a reprint of the FDA Alert. CRM Laboratories Issues a Voluntary Nationwide Recall of X-ROCK 3 Day Pill For Men and Z-ROCK All Natural Male Supplement Products Marketed as Dietary Supplements to Support Male Sexual Performance Due to Undeclared Active Ingredients FOR IMMEDIATE RELEASE – July 20, 2012…
[...]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…
[...]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.
[...]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…
[...]FDA Alert: Second Counterfeit Version of Cancer Drug Found in U.S.
This is a reprint of the FDA alert. Altuzan (bevacizumab): Counterfeit Product – Contains no Active Ingredient ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved…
[...]Dietary Supplements Recalled Due to Sibutramine and Tadalafil
This is a reprint of the Company Safety Recall posted on the FDA website. February 22, 2012 – Healthy People Co. announced today that is expanding its voluntary nationwide recall of the company’s dietary supplements sold under the brand names described below, regardless of the lot numbers referenced herein, and to the extent these products were…
[...]FDA Alert: Counterfeit Version of Avastin in U.S. Distribution
This is a reprint of the FDA Safety Alert. FDA sends letters to 19 medical practices about counterfeit product and other unapproved cancer medicines The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical…
[...]Alert: Unapproved Drug Found in RegenArouse, Recalled by Maker
This is a reprint of the FDA alert. Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The…
[...]Alert: Counterfeit Phentermine Found in the U.S.
This is a reprint from Actavis. Actavis Elizabeth LLC is warning consumers and healthcare professionals that counterfeit Phentermine HCl Tablets (USP 37.5 mg) that contain fenfluramine, a dangerous ingredient, have been found in the United States. Phentermine is an appetite suppressant medicine that Actavis has not distributed in the U.S. since 2008 and does not…
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