Drugs
Resources for You
- McNeil Healthcare Establishment Inspection Reports/483s
- McNeil Consumer Healthcare Inc. 483 issued 12/09/2010 (PDF - 3.3MB)
- FDA Testimony (May 27, 2010)
- FDA Testimony (Sept. 30, 2010)
- FDA provides consumer advice following recall of products for infants and children (May 1, 2010)
Questions and answers on voluntary recall of certain liquid infant’s and children’s Tylenol, Motrin, Zyrtec, and Benadryl products - MedWatch Safety Alert (with McNeil Consumer Healthcare firm releases)
Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Buildings and Facilities
McNeil Healthcare and Johnson and Johnson Merck Recalls
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), has voluntarily recalled certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured nationwide and internationally.
Recalling Firm | Product Description | Public Reason for Recall | Posted on FDA’s Website |
|---|---|---|---|
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. | TYLENOL®, Extra Strength Caplets, 225 count | uncharacteristic musty, moldy odor | Recall of Products 6/28/11 |
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. | TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products | insufficient development during manufacturing | Recall of Products 1/14/11 |
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. | ROLAIDS Extra Strength Softchews, ROLAIDS Extra Strength plus Gas Softchews, and ROLAIDS Multi-Symptom plus Anti-Gas Softchews | foreign materials in product | Recall of ROLAIDS Products 12/9/10 |
Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. | Mylanta and Alternagel Liquid Products | mislabeled -alcohol content not listed on front panel | Recall of Mylanta and Alternagel Liquid Products 11/29/10 |
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. | Tylenol Cold Multi Symptom Daytime Liquid 8 oz Citrus Burst | mislabeled - alcohol content not listed on front panel | Recall of Tylenol Cold Liquid Products |
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. | Rolaids Extra Strength Softchews, Cherry Flavor, 36 count container | uncharacteristic consistency - crystallized sugar | Recall of ROLAIDS® Extra Strength Softchews |
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. | Jr Strength Motrin Caplets in 24 count packages | insufficient development during manufacturing | Recall of Children's BENADRYL® Allergy FASTMELT® Tablets and Junior Strength MOTRIN® Caplets |
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. | Children's Benadryl Allergy FastMelt Tablets Cherry Flavor in 18 count containers | insufficient development of manufacturing process | Recall of Children's BENADRYL® Allergy FASTMELT® Tablets and Junior Strength MOTRIN® Caplets |
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. | Tylenol 8 hour Caplets in 50 count bottles | off odor - musty/moldy | Recall of One Product Lot of TYLENOL® 8 Hour Caplets 50 Count Posted 10/18/2010 |
Johnson & Johnson Merck, Ft Washington, PA | 1) PEPCID Complete Tablet, 10 mg, 800 mg, 165 mg; 50 count bottles. | Defective Container: small number of bottles have been punctured at the bottom edge during the packaging process. | Recall initiated 8/2010 |
Blacksmith Brands, Inc., Tarrytown, NY. | 1) PediaCare Children's Multi-Symptom Cold, Grape Flavor Liquid, 4 fl oz (118 mL) 2) PediaCare Children's Long-Acting Cough, Grape Flavor Liquid, 4 fl oz (118 mL) 3) PediaCare Children's Decongestant, Raspberry Flavor Liquid, 4 fl oz (118 mL) 4) PediaCare Children's Allergy & Cold, Grape Flavor Liquid, 4 fl oz (118 mL) | GMP deficiencies at manufacturing site. | Recall of Four PediaCare Children's Products Posted: 5/28/10 |
Johnson & Johnson Consumer Group of Companies, Inc., Skillman, NJ | Sterile Visine All Day Eye Itch Relief Opthalmic Solution Antihistamine Eye Drops ; 0.17oz (5 ml) bottle | Failed PH Specifications | Recall initiated 3/2010 |
