Safety Alerts & Recalls

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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:
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McNeil Now Recalls All Lots of Three Rolaids Heartburn Products
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare has issued a new recall for Rolaids products. This recall includes all product lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed in the United States. These products are being recalled because of consumer complaints of foreign materials in the product, including metal and wood particles. The company has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to stop using them. For more information and a detailed list of recalled Rolaids products, please visit:
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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
2010-12-10 McNeil Now Recalls All Lots of Three Rolaids Heartburn Products Calcium Carbonate with Magnesium Hydroxide Manufacturer
2010-12-02 Johnson and Johnson Recalls Several Mylanta and AlternaGel Liquid Products FDA
2010-11-29 McNeil Issues Another Recall: Tylenol Cold Multi-Symptom Liquid Products Tylenol Cold Multisymtom Plus Coug Manufacturer
2010-11-29 Teva Recalls Single Lot of Tamoxifen Tamoxifen FDA
2010-11-29 Vintage and Qualitest Pharmaceuticals Recall a Single Lot of Prednisone Tamoxifen FDA
2010-11-24 McNeil Issues Another Recall: Children's Benadryl Allergy Fastmelt Tablets Diphenhydramine Manufacturer
2010-11-24 McNeil Issues Another Recall: Rolaids Extra Strength Softchews Calcium Carbonate with Magnesium Hydroxide Manufacturer
2010-11-24 McNeil Issues Another Recall: Junior Strength Motrin Caplets Ibuprofen Manufacturer
2010-11-19 FDA Recommends Against the Continued Use of Propoxyphene (Darvon, Darvocet, and Others) Propoxyphene HCl FDA
2010-11-05 Vitamin E Linked to Certain Types of Stroke MediGuard CRT
2010-11-04 Actavis Issues Consumer Update to Recall of Fentanyl Transdermal System 25 mcg/h Patches Fentanyl Manufacturer
2010-11-04 Medical Products Laboratories, Inc. Recalls Single Lot of NaFrinse Sodium Fluoride FDA
2010-11-04 Blenheim Pharmacal Recalls Sulfamethoxazole and Trimethoprim DS Tablets Sulfamethoxazole with Trimethoprim FDA
2010-11-03 Discontinuation of Original Prefilled Pens for Humalog and Humalog Mix Insulin Lispro and Insulin Lispro Protamine Manufacturer
2010-11-01 B. Braun Recalls Several Lots of Heparin Heparin FDA
2010-10-31 Pfizer Recalls Two More Lots of Lipitor 40 mg Tablets Due To Strange Smell Atorvastatin Manufacturer
2010-10-29 Sandoz Issues Voluntary Recall of Methotrexate Injection Vials Methotrexate Manufacturer
2010-10-28 Sanofi-Aventis Recalls Single Lot of Apidra SoloStar Insulin Glulisine FDA
2010-10-28 FDA Issues Reminder to Avoid Concomitant Use of Plavix (Clopidogrel) and Omeprazole (Prilosec, Prilosec OTC, Zegerid, Zegerid OTC) Clopidogrel FDA