Safety Alerts & Recalls

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Latest Alerts

Zicam Extreme Congestion Relief Nasal Gel Recalled Because of Bacteria Contamination
Matrixx Initiatives has recalled one lot of Zicam Extreme Congestion Relief nasal gel. The bacteria Burkholderia cepacia was found in a single sample of the product taken from the lot 2J23, with the expiration date 09/15. The problem was detected during a routine review at the manufacturing facility. Although tests on additional samples from the same lot have shown no evidence of the bacteria, the manufacturer is recalling lot 2J23 as a precaution. Zicam Congestion Relief nasal gel is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a 0.5 oz. spray bottle contained in an outer carton, bearing a product NDC number 62750-005-10. No other Zicam products were involved in this recall. For more information, please visit:
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FDA Warns That Hepatitis C Drug Incivek Can Cause Potentially Fatal Skin Reactions
The U.S. Food and Drug Administration (FDA) has received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin. Some patients died when they continued to receive Incivek combination treatment after developing a worsening or progressive rash and systemic symptoms (symptoms affecting the entire body). The FDA is adding a boxed warning to the Incivek drug label stating that Incivek combination treatment must be immediately stopped in patients experiencing a rash with systemic symptoms or a progressive severe rash. Typical systemic symptoms and signs may include fever, nausea, diarrhea, mouth sores or ulcers, facial swelling (edema), red or inflamed eyes, or swelling or inflammation of the liver (hepatitis). Incivek is a protease inhibitor used in combination with peginterferon alfa and ribavirin for the treatment for hepatitis C in adult patients. For more information, please visit:
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Date Published Title Drug Source
2012-12-19 Zicam Extreme Congestion Relief Nasal Gel Recalled Because of Bacteria Contamination Manufacturer
2012-12-19 FDA Warns That Hepatitis C Drug Incivek Can Cause Potentially Fatal Skin Reactions Telaprevir FDA
2012-12-20 Pradaxa Contraindicated in Patients With Mechanical Heart Valves Dabigatran FDA
2013-01-02 Johnson and Johnson Recalls Several Lots of Clean & Clear Advantage, 3-in-1 foaming Wash Salicylic Acid FDA
2013-01-02 Genentech USA, Inc. Recalls Several Lots of CellCept Capsules, 250 mg Mycophenolate FDA
2013-01-02 Watson Pharma Recalls Select Lots of Caziant (Desogestrel and Ethinyl Estradiol) Tablets Desogestrel with Ethinylestradiol FDA
2013-01-03 Physicians Total Care Recalls Several Lots of Enjuvia Tablets Estrogens Conjugated FDA
2013-01-10 FDA Lowers Recommended Dose of Sedative Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) Zolpidem FDA
2013-01-14 Mylan Pharmaceuticals Inc. Recalls Several Lots of Tacrolimus Capsules 0.5 mg Tacrolimus FDA
2013-01-14 Abbott Laboratories Recalls Single Lot of Synthroid tablets, 150 mcg Levothyroxine FDA
2013-01-18 Rugby Natural Iron Supplement Recalled Because Bottle May Contain Nausea Medicine Meclizine Iron FDA
2013-02-03 Novartis Recalls Several Lots of Triaminic® and Theraflu Warming Relief® Syrups Manufacturer
2013-02-25 Affymax and Takeda Announce a Recall of All Lots of Omontys (Peginesatide) Injection Peginesatide Manufacturer
2013-03-12 FDA Warns of Abnormal Heart Rhythms with Azithromycin (Zithromax or Zmax) Azithromycin FDA
2013-03-15 FDA Studies Possible Pancreatic Risk With Class of Diabetes Drugs Sitagliptin FDA
2013-04-01 FDA Allows Changes to the Warnings and Directions for Use of Nicotine Patches, Gum, and Lozenges Nicotine FDA
2013-04-19 One Touch Verio IQ and FreeStyle lnsulinx Blood Glucose Meters Recalled Insulin Lispro and Insulin Lispro Protamine FDA
2013-04-26 Saratoga Therapeutics, LLC Recalls ebA Multivitamin Supplement Due to Undeclared Milk Components Multivitamin FDA
2013-04-29 Anti-Seizure Medicine Potiga (Ezogabine) Linked to Eye Problems and Blue Skin Discoloration Ezogabine FDA
2013-05-01 FDA Updates Prescribing Information for Samsca: Limits Use Tolvaptan FDA