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Reese Pharmaceutical Company Recalls Certain Over-The-Counter Cold Relief Products That Are Mislabeled
Reese Pharmaceutical Company has voluntarily recalled four different brand name cold products containing Guaifenesin 200 mg tablets. Specifically, 60-count size bottles from lot number 091612 were mislabeled and do not contain a complete listing of all ingredients. The mislabeled product contains Acetaminophen 325 mg, Phenylephrine 5 mg, and Chlorpheniramine Maleate 2 mg in addition to Guaifenesin 200 mg. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine or chlorpheniramine. The four different brand names with their product NDC numbers include: Refenesen Expectorant (guaifenesin 200 mg tablets) NDC 10956-752-60 Select Brand Mucus Relief Expectorant (guaifenesin 200 mg) NDC 15127-129-60 QC Medifin Expectorant (guaifenesin 200 mg) NDC 63868-754-60 Leader Cough Tabs Expectorant (guaifenesin 200 mg) NDC 37205-466-72 The mislabeled product does not warn consumers that ingesting high doses of acetaminophen can potentially cause severe liver damage, especially among consumers with pre-existing liver disease and those who drink three or more alcoholic drinks per day. Overdose is more likely to occur if consumers are also taking other cold/cough products that contain acetaminophen in addition to the mislabeled product. Phenylephrine should be avoided in patients with high-blood pressure, poor blood flow to the extremities, and patients on antidepressants known as MAO Inhibitors. Products that contain phenylephrine should be used with caution in patients with high blood pressure, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. Consumers who are allergic to any of the ingredients or who have narrow angle glaucoma, or are pregnant or nursing mothers, also should not take the product. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm236509.htm
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Generic Manufacturer Recalls Several Drug Products
Actavis Totowa LLC, a generic drug manufacturer, has voluntarily recalled all drug products manufactured at its Little Falls, New Jersey facility. An FDA inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. This recall includes all AMITEX PSE tablets manufactured by Actavis Totowa, LLC. For more information, please visit: http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112477.htm or http://www.actavis.us/RecallFAQ
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Date Published Title Drug Source
2010-12-13 Reese Pharmaceutical Company Recalls Certain Over-The-Counter Cold Relief Products That Are Mislabeled Guaifenesin Manufacturer
2008-08-04 Generic Manufacturer Recalls Several Drug Products Guaifenesin / Pseudoephedrine Manufacturer
2009-01-29 Recall on All ETHEX Brand Guaifenex PSE and Pseudovent Guaifenesin / Pseudoephedrine Manufacturer
2008-11-25 Recall of Several Lots of Bidex-DMI Cold Medicine with Guaifenesin and Dextromethorphan Guaifenesin with Dextromethorphan FDA
2009-02-01 Recall on All ETHEX Brand Guaifenesin with Dextromethorphan Guaifenesin with Dextromethorphan FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of Q-Tussin DM and Iophen DM-NR Liquid Guaifenesin with Dextromethorphan FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Guanfacine Manufacturer
2007-09-18 New warnings for intravenous and high dose use Haloperidol Manufacturer
2008-06-17 New Boxed Warning on Older Class of Antipsychotic Drugs Haloperidol FDA
2009-01-15 Antipsychotics Linked to Heart Risks Haloperidol MediGuard CRT
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Haloperidol MediGuard CRT
2009-02-05 Recall on Ther-Rx Brand Iron Supplements Manufacturer
2010-11-01 B. Braun Recalls Several Lots of Heparin Heparin FDA
2008-12-17 Addressing Questions About Gardasil Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18) Vac FDA
2011-08-02 FDA Report Cites Customer Complaints of Shrink Wrap Found in Vaccine Vials Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18) Vac FDA
2011-07-19 Teva Recalls Several Lots of Hydralazine Tablets, 10 mg, 25 mg, 50 mg and 100 mg Hydralazine FDA
2012-01-04 Teva Pharmaceuticals USA Recalls Single Lot of Hydralazine Hydrochloride Tablets, USP, 25 mg Hydralazine FDA
2010-10-04 Bristol-Myers Squibb Co. is Recalling 60 Million Tablets of Avalide Hydrochlorothiazide with Irbesartan Manufacturer
2011-01-15 Bristol-Myers Squibb Recalls Additional Avalide Tablets Hydrochlorothiazide with Irbesartan Manufacturer
2008-08-12 Angioedema and ACE inhibitors Hydrochlorothiazide with Moexipril Hydrochloride MediGuard CRT
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