Safety Alerts & Recalls

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Johnson and Johnson Recalls Several Mylanta and AlternaGel Liquid Products
In consultation with the U.S. Food and Drug Administration (FDA), Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. (JJMCP) is recalling twelve Mylanta liquid products and one AlternaGel liquid product. JJMCP initiated the recall after an internal review revealed that information about the presence of alcohol was not clearly displayed on the front product label. The presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (< 1%) amounts of alcohol. JJMCP is conducting the recall in order to update the labeling for these products. The full recalled product list includes: Mylanta Regular Strength Original 12 FL OZ - NDC 16837-162-12 Mylanta Original 5 FL OZ - NDC 16837-162-55 Mylanta Regular Strength Mint 12 FL OZ - NDC 16837-138-12 Mylanta Maximum Strength Cherry 12 FL OZ - NDC 16837-136-12 Mylanta Maximum Strength Mint 12 FL OZ - NDC 16837-137-12 Mylanta Maximum Strength Original 12 FL OZ - NDC 16837-163-12 Mylanta Maximum Strength Original 24 FL OZ - NDC 16837-163-24 Mylanta Ultimate Strength Mint 12 FL OZ - NDC 16837-643-12 Mylanta Ultimate Strength Cherry 12 FL OZ - NDC 16837-644-12 Mylanta Supreme Tasting with Calcium Cherry 12 FL OZ - NDC 16837-825-12 Mylanta Supreme Tasting with Calcium Cherry 24 FL OZ - NDC 16837-825-24 Mylanta Maximum Strength Original 12 FL OZ - NDC 16837-163-12 Alternagel 12 FL OZ - NDC 16837-860-12 The affected product name and NDC numbers can be found on the product's front panel. This recall is at the wholesale and retail level. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product. For more information and a full list of recalled lot numbers, please visit: http://www.fda.gov/Safety/Recalls/ucm235376.htm
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McNeil Issues Another Recall: Tylenol Cold Multi-Symptom Liquid Products
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare has issued a voluntary recall of all product lots of three Tylenol Cold Multi-Symptom liquid products sold in the United States. McNeil Consumer Healthcare initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (< 1%) amounts of alcohol. The recall was issued in order to update the labeling for these products. The full recalled product list includes: Tylenol Cold Multi-Symptom Daytime 8 oz Citrus Burst Liquid - NDC 50580-257-08 Tylenol Cold Multi-Symptom Nightime 8 oz Cool Burst Liquid - NDC 50580-269-08 Tylenol Cold Multi-Symptom Severe 8 oz Cool Burst Liquid - NDC 50580-351-08 The affected product name and NDC numbers can be found on the product's front panel. This recall is at the wholesale and retail level. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product. For more information, please visit: http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_5.inc
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Date Published Title Drug Source
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
2010-10-27 Apotex Corp Recalls Single Lot of Oxybutynin Oral Solution Oxybutynin FDA
2010-10-27 Fresenius Recalls Single Lot of PhosLo GelCaps Calcium Acetate FDA
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