Microsoft word - final dear warehouse communication letter.doc

McNeil Consumer Healthcare, 7050 Camp Hill Road, Fort Washington, PA 19034
URGENT – DRUG RECALL
Dear OTC Warehouse:
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. is recalling certain lot codes of OTC products (full list below).
To minimize the impact to your business and help ensure uninterrupted access to medicines not impacted by this action,
please consult the list of products below prior to removing from the shelf.

Please return ALL warehouse and retail inventory of the below lot codes. No product other than the ones specified
should be returned.
McNeil Consumer Healthcare is initiating this voluntary recall following an investigation of consumer reports of an
unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-
serious gastrointestinal events. These include nausea, stomach pain, vomiting, or diarrhea. This precautionary action is
voluntary and has been taken in consultation with the FDA.

Based on this investigation, McNeil Consumer Healthcare has determined that the reported uncharacteristic smell is caused
by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of
a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging
materials. The health effects of this chemical have not been well studied but no serious events have been documented in the
medical literature. A small number of the product lots being recalled were associated with the complaints of an unusual
moldy, musty, or mildew-like odor, and some of these lots were found to contain trace amounts of TBA. In December
2009, McNeil Consumer Healthcare also recalled all lots of TYLENOL® Arthritis Pain 100 count with EZ-OPEN CAP
related to this issue. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots
that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints.
In addition to the product recall, McNeil Consumer Healthcare is continuing their investigation into this issue and is taking
further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and
requiring suppliers who ship materials to our plants to discontinue the use of these pallets. We will continue to closely
monitor and evaluate the situation and consult with the FDA.
Action Requested:

1. Identify all warehouse inventory of below listed products and return immediately as per the attached “Return
Authorization Form”. If you have any questions regarding the form, please call Stericycle at 877-830-9729. You can also fax your questions to fax 888-345-2670. 2. Communicate this product recall to your retail outlets that received these products and request they return ALL
identified products to your warehouse. Please place all inventory and returns of these products into quarantine in your warehouse until returned to Stericycle. A suggested communication is attached for your use. 3. Once you have all retail returns, send back immediately per enclosed instructions. 4. Please complete the enclosed Business Reply Form and return as soon as possible. We appreciate your cooperation in helping us successfully execute this voluntary recall. If you have any questions related to the product, please contact your McNeil Consumer Healthcare Sales Representative or call 888-222-6036. You can also log into the internet at www.mcneilproductrecall.com for information pertaining to this recall. McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. Product Name
Lot Number
CHILDREN'S CAPLET
CHILDREN'S MELTAWAY Children's Tylenol Bubble Gum Meltaway
Children's Tylenol Grape Meltaways Tablet BENADRYL
STRENGTH
Product Name
Lot Number
STRENGTH
Product Name
Lot Number
STRENGTH
Extra Strength Tylenol Cool Caplet 50 ct Extra Strength Tylenol Cool Caplet 100 ct Product Name
Lot Number
STRENGTH
Extra Strength Tylenol Rapid Release Gelcap Product Name
Lot Number
STRENGTH
MOTRIN IB
Product Name
Lot Number
MOTRIN IB
Product Name
Lot Number
MOTRIN IB
STRENGTH
Product Name
Lot Number
STRENGTH
Product Name
Lot Number
Extra Strength Rolaids Fresh Mint Tablet Extra Strength Rolaids Fruit Tablet 100 ct Multi Symptom Rolaids Berry Tablet 100 ct Product Name
Lot Number
Original Rolaids Peppermint Tablet 150 ct Product Name
Lot Number
ST. JOSEPH
St. Joseph Aspirin Chewable Orange Tablet St. Joseph Aspirin Chewable Orange Tablet St. Joseph Aspirin Enteric Coated Tablet St. Joseph Aspirin Enteric Coated Tablet St. Joseph Aspirin Enteric Coated Tablet Product Name
Lot Number
ST. JOSEPH
St. Joseph Aspirin Enteric Coated Tablet ARTHRITIS
Product Name
Lot Number
ARTHRITIS
Extra Strength Tylenol PM Caplet 24+12 ct Extra Strength Tylenol PM Caplet 100+20 ct Product Name
Lot Number
Extra Strength Tylenol PM Caplet 225 ct Extra Strength Tylenol PM Geltab 50+20 ct

Source: http://www.mrwilliams.com/uploads/file/Final%20Dear%20Warehouse%20Communication%20Letter.pdf