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U.S. Department of Health and Human Services

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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
Sat, 27 Nov 2010 09:42:00 -0600

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
Sat, 27 Nov 2010 08:12:00 -0600

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
Sat, 27 Nov 2010 08:22:00 -0600

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
Sat, 27 Nov 2010 08:22:00 -0600

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.
2) PEPCID AC Tablets, 10 mg, 90 Count Bottle.

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.
Manufacturer: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA.

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
 

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