McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji

FORT WASHINGTON, Pa., Jan. 15 /PRNewswire/ -- In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is voluntarily recalling certain lots of OTC products in the Americas, the United Arab Emirates (UAE), and Fiji (FULL RECALLED PRODUCT LIST BELOW).  The company is initiating this 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.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement.   For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).  Consumers who have medical concerns or questions should contact their healthcare provider.  Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The affected product lot numbers for the recalled products can be found on the side of the bottle label.

McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a broad range of well-known and trusted over-the-counter (OTC) products.

.

FULL RECALLED PRODUCT LIST:




Product Form

Product Name

Lot Number

UPC Code

CHILDREN'S

CAPLET

Junior Strength Motrin IB Caplet 24 ct

AJM322

300450498243

MOTRIN



APM348

300450498243


CHEWABLE

Junior Strength Motrin Grape Chewable

ADM006

300450909244



Grape  24 ct

ADM052

300450909244




AFM016

300450909244




AFM350

300450909244




AHM420

300450909244




AJM346

300450909244




ALM344

300450909244




ALM399

300450909244




AMM379

300450909244




APM303

300450909244




APM418

300450909244




APM429

300450909244




SLM084

300450909244



Junior Strength Motrin Orange Chewable

ADM013

300450494245



Tablet 24 ct

AFM024

300450494245




AHM402

300450494245




AJM345

300450494245




ALM326

300450494245




ALM456

300450494245




AMM381

300450494245




APM306

300450494245




APM421

300450494245

CHILDREN'S

MELTAWAY

Children's Tylenol Bubble Gum Meltaway

AHA069

300450519306

TYLENOL


Tablet 30 ct

SPA022

300450519306



Children's Tylenol Grape Meltaways Tablet

AHA023

300450518309



30 ct

AHA057

300450518309

BENADRYL

TABLET

Benadryl Allergy Tablet 148 ct

AAA422

300450226143




ABA392

300450226143




AJA094

300450226143




ALA034

300450226143

EXTRA

CAPLET

Extra Strength Tylenol Caplet 24 ct

AAA408

300450449054

STRENGTH



ABA169

300450449054

TYLENOL



ABA568

300450449054




ADA192

300450449054




AHA048

300450449054




AJA145

300450449054


Product Form

Product Name

Lot Number

UPC Code

EXTRA

 CAPLET

Extra Strength Tylenol Caplet 24+12 ct

ABA565

300450444318

STRENGTH



AHA040

300450444318

TYLENOL



AJA028

300450444318



Extra Strength Tylenol Caplet 50 ct

24862

350580451502




24881

350580451502




24901

350580451502




24970

350580451502




25994

350580451502




26054

350580451502




26213

350580451502




26305

350580451502




26356

350580451502




26377

350580451502




26515

350580451502




26541

350580451502




AEA206

300450449078




AFA176

300450449078




AFA325

300450449078




AHA072

300450449078




AJA021

300450449078



Extra Strength Tylenol Caplet 50+25 ct

ACA599

300450444752




ACA755

300450444752



Extra Strength Tylenol Caplet 100 ct

AMA008

300450449092




SSA013

300450449092




SSA150

300450449092



Extra Strength Tylenol Caplet 100+25 ct

SDA203

300450449009




SHA035

300450449009



Extra Strength Tylenol Caplet 150 ct

AAA419

300450449238




SEA199

300450449238




SPA007

300450449238



Extra Strength Tylenol Caplet 150+50 ct

SFA071

300450449467



Extra Strength Tylenol Caplet 225 ct

SSA011

300450444271



Extra Strength Tylenol Caplet 325 ct

09BMC018

300450444325




09CMC048

300450444325




09FMC082

300450444325




09FMC084

300450444325




AAA405

300450444325




ADA014

300450444325




ADA087

300450444325


Product Form

Product Name

Lot Number

UPC Code

EXTRA

 CAPLET

 Extra Strength Tylenol Caplet 325 ct

ADA270

300450444325

STRENGTH



ADA271

300450444325

TYLENOL



ADA417

300450444325




AEA348

300450444325




AFA102

300450444325




AJA045

300450444325




ALA028

300450444325




SFA179

300450444325




SFA237

300450444325




SFA295

300450444325




SHA002

300450444325




SJA025

300450444325




SJA189

300450444325




SJA232

300450444325




SLA004

300450444325




SLA160

300450444325




SLA296

300450444325




SMA173

300450444325




SMA174

300450444325




SPA005

300450444325




SPA038

300450444325




SPA058

300450444325




SPA386

300450444325




SSA055

300450444325


COOL

Extra Strength Tylenol Cool Caplet 50 ct

ABA029

300450444509


CAPLET


ACA563

300450444509




ADA190

300450444509




AHA081

300450444509




AJA095

300450444509




AJA175

300450444509



Extra Strength Tylenol Cool Caplet 100 ct

ALA249

300450444103


EZ TABLET

Extra Strength Tylenol EZ Tab 24 ct

ABA154

300450422248




ADA193

300450422248




AFA243

300450422248




AHA039

300450422248



Extra Strength Tylenol EZ Tab 50 ct

ADA013

300450422507




AEA259

300450422507




AHA091

300450422507


Product Form

Product Name

Lot Number

UPC Code

EXTRA

 EZ TABLET

Extra Strength Tylenol EZ Tab 50 ct

AJA010

300450422507

STRENGTH



AJA123

300450422507

TYLENOL


Extra Strength Tylenol EZ Tab 50+25 ct

ACA562

300450422750




ACA743

300450422750




ALA173

300450422750


RAPID

Extra Strength Tylenol Rapid Release

ABA020

300450488244


RELEASE

Gelcap 24 ct

ABA371

300450488244


GELCAP


ADA280

300450488244




AHA082

300450488244



Extra Strength Tylenol Rapid Release

ACA451

300450488503



Gelcap 50 ct

AEA061

300450488503




AEA244

300450488503




AFA103

300450488503




AFA240

300450488503




AHA046

300450488503




AHA080

300450488503




AJA040

300450488503




AJA041

300450488503



Extra Strength Tylenol Rapid Release

ALA253

300450488176



Gelcap 100+20 ct

AMA015

300450488176



Extra Strength Tylenol Rapid Release Gelcap 150 ct

ASA015

300450488152



Extra Strength Tylenol Rapid Release

09AMC008

300450488213



Gelcap 290 ct

AAA049

300450488213




AAA360

300450488213




ADA022

300450488213




ADA178

300450488213




ADA272

300450488213




ADA482

300450488213




AEA194

300450488213




AFA010

300450488213




AFA292

300450488213




AHA035

300450488213




AHA089

300450488213




AJA167

300450488213




ALA095

300450488213




ALA096

300450488213




SEA191

300450488299




SEA192

300450488299


Product Form

Product Name

Lot Number

UPC Code

EXTRA

RAPID

Extra Strength Tylenol Rapid Release

SFA025

300450488299

STRENGTH

RELEASE

Gelcap 290 ct

SFA026

300450488299

TYLENOL

GELCAP


SFA136

300450488299




SFA296

300450488213




SHA039

300450488213




SHA234

300450488213




SLA052

300450488299




SLA198

300450488299




SLA270

300450488213




SMA236

300450488213




SPA037

300450488213




SPA357

300450488213




SSA019

300450488213




SSA030

300450488213




SSA054

300450488213


TABLET

Extra Strength Tylenol Tablet 60 ct

AEA243

300450499684

MOTRIN IB

CAPLET

Motrin IB Caplet  24 ct

AAA435

300450481030




ABA369

300450481030




ADA174

300450481030




AHA026

300450481030




AJA006

300450481030



Motrin IB Caplet  24+6 ct

ADA246

300450481641



Motrin IB Caplet  50 ct

ABA153

300450481023




ABA541

300450481023




ADA173

300450481023




AHA025

300450481023



Motrin IB Caplet  100 ct

ABA019

300450481016




ACA469

300450481016




ADA245

300450481016




AEA260

300450481016




AFA015

300450481016




AJA049

300450481016




AJA186

300450481016



Motrin IB Caplet  100+25 ct

ADA287

300450481955




AFA016

300450481955



Motrin IB Caplet  100+50 ct

ABA538

300450481757




AJA023

300450481757




AJA120

300450481757



Motrin IB Caplet  225 ct

24526

300450481627


Product Form

Product Name

Lot Number

UPC Code

MOTRIN IB

CAPLET

 Motrin IB Caplet  225 ct

24544

300450481627




24591

300450481627




24604

300450481627




24634

300450481627




24687

300450481627




24762

300450481627




24794

300450481627




24795

300450481627




24818

300450481627




24864

300450481627




24905

300450481627




24915

300450481627




24935

300450481627




24939

300450481627




24977

300450481627




25013

300450481627




25044

300450481627




25980

300450481627




25996

300450481627




26051

300450481627




26085

300450481627




26134

300450481627




26192

300450481627




26241

300450481627




26335

300450481627




26423

300450481627




26455

300450481627




26508

300450481627




26533

300450481627



Motrin IB Caplet  300 ct

ACA442

300450481375




ACA759

300450481375




ADA018

300450481375




ADA419

300450481375




AFA098

300450481375




AFA112

300450481375




AHA034

300450481375




AHA068

300450481375




ALA254

300450481375




ALA359

300450481375


Product Form

Product Name

Lot Number

UPC Code

MOTRIN IB

CAPLET

 Motrin IB Caplet  300 ct

AMA177

300450481375




AMA350

300450481375




APA217

300450481375




SEA208

300450481375




SFA184

300450481375




SFA259

300450481375




SHA107

300450481375




SJA131

300450481375




SLA049

300450481375




SLA162

300450481375




SMA013

300450481375




SMA082

300450481375




SSA157

300450481375


TABLET

Motrin IB Tablet 24 ct

ABA003

300450463029




ADA258

300450463029




AFA309

300450463029




AJA055

300450463029



Motrin IB Tablet 50 ct

ABA004

300450463036




ABA152

300450463036




AFA228

300450463036




AHA024

300450463036




AJA007

300450463036




AJA243

300450463036



Motrin IB Tablet 100 ct

AEA078

300450463043




AEA261

300450463043




AFA241

300450463043



Motrin IB Tablet 100+25 ct

AFA017

300450463296




AJA168

300450463296



Motrin IB Tablet 100+50 ct

ALA109

300450463753

REGULAR

CAPLET

Regular Strength Tylenol Caplet 50 ct

24777

350580501504

STRENGTH



24900

350580501504

TYLENOL



24971

350580501504




25971

350580501504




26019

350580501504




26133

350580501504




26271

350580501504




26422

350580501504




26482

350580501504




26521

350580501504


Product Form

Product Name

Lot Number

UPC Code

REGULAR

TABLET

Regular Strength Tylenol Tablet 100 ct

ABA148

300450496607

STRENGTH



ABA266

300450496607

TYLENOL



ABA373

300450496607




ACA432

300450496607




AFA101

300450496607




AHA070

300450496607




AJA009

300450496607




ALA099

300450496607




AMA018

300450496607

ROLAIDS

CHEWABLE

Extra Strength Rolaids Freshmint Tablet

AAA011

312547650212



100 ct

AAA083

312547650212




AAA399

312547650212




ABA397

312547650212




ACA439

312547650212




ADA086

312547650212




ADA180

312547650212




AEA197

312547650212




AEA250

312547650212




AFA053

312547650212




AFA224

312547650212




AFA293

312547650212




AJA043

312547650212




AJA114

312547650212




ALA105

312547650212




ALA159

312547650212




ALA273

312547650212




AMA178

312547650212




APA054

312547650212




SJA113

312547650212




SJA114

312547650212




SJA115

312547650212




SJA116

312547650212




SJA259

312547650212




SLA149

312547650212




SMA032

312547650212




SMA222

312547650212




SMA248

312547650212




SPA024

312547650212




SPA128

312547650212


Product Form

Product Name

Lot Number

UPC Code

ROLAIDS

CHEWABLE

Extra Strength Rolaids Fresh Mint Tablet

SPA161

312547650212



100 ct

SSA351

312547650212



Extra Strength Rolaids Fruit Tablet 100 ct

AAA086

312547650243




ABA262

312547650243




ACA256

312547650243




ADA028

312547650243




ADA082

312547650243




AEA195

312547650243




AFA234

312547650243




AJA017

312547650243




AJA018

312547650243




AJA180

312547650243




ALA026

312547650243




AMA051

312547650243




AMA208

312547650243




APA152

312547650243




SMA031

312547650243




SMA099

312547650243




SMA100

312547650243




SMA101

312547650243




SSA331

312547650243




SSA332

312547650243



Extra Strength Rolaids Tropical Punch

AAA359

312547654234



Tablet 100 ct

SHA016

312547654234




SHA017

312547654234




SHA018

312547654234




SJA204

312547654234




SLA151

312547654234




SSA175

312547654234



Multi Symptom Rolaids Berry Tablet 100 ct

ABA009

312547654579




ABA010

312547654579




ABA011

312547654579




ABA417

312547654579




ABA620

312547654579




ACA438

312547654579




ALA256

312547654579




APA042

312547654579




ASA012

312547654579



Original Rolaids Cherry Tablet 150 ct

ACA013

312547652421


Product Form

Product Name

Lot Number

UPC Code

ROLAIDS

CHEWABLE

 Original Rolaids Cherry Tablet 150 ct

AEA057

312547652421




AFA317

312547652421




AJA016

312547652421




AMA165

312547652421




APA009

312547652421




SLA087

312547652421




SPA036

312547652421




SSA334

312547652421




SSA438

312547652421



Original Rolaids Peppermint Tablet 150 ct

AAA009

312547651158




AAA202

312547651158




AAA232

312547651158




ABA141

312547651158




ABA268

312547651158




ABA416

312547651158




ABA554

312547651158




ACA567

312547651158




ADA268

312547651158




AEA072

312547651158




AFA009

312547651158




AFA171

312547651158




AJA178

312547651158




AMA024

312547651158




AMA267

312547651158




AMA268

312547651158




APA041

312547651158




SJA110

312547651158




SJA111

312547651158




SJA112

312547651158




SJA148

312547651158




SLA084

312547651158




SLA217

312547651158




SLA367

312547651158




SLA370

312547651158




SMA123

312547651158




SMA124

312547651158




SMA332

312547651158




SPA129

312547651158




SSA439

312547651158


Product Form

Product Name

Lot Number

UPC Code

SIMPLY

CAPLET

Simply Sleep Mini Caplet 100 ct

ADM015

300450843104

 SLEEP



ADM016

300450843104




AFM014

300450843104




AFM352

300450843104




AJM319

300450843104




AJM364

300450843104




ALM387

300450843104




AMM436

300450843104




AMM438

300450843104

ST. JOSEPH

CHEWABLE

St. Joseph Aspirin Chewable Orange Tablet

AHM440

300450173362

ASPIRIN


36 ct

AMM325

300450173362




APM430

300450173362



St. Joseph Aspirin Chewable Orange Tablet

AFM360

300450173089



3X36 ct

AHM423

300450173089




ALM346

300450173089




AMM434

300450173089


TABLET

St. Joseph Aspirin Enteric Coated Tablet

AFM026

300450126368



36 ct

AHM327

300450126368




AHM432

300450126368




AJM321

300450126368




ALM327

300450126368




AMM324

300450126368




APM349

300450126368




APM420

300450126368



St. Joseph Aspirin Enteric Coated Tablet

AEM050

300450126108



100 ct

AHM374

300450126108




AJM320

300450126108




AJM402

300450126108




ALM341

300450126108




AMM365

300450126108




AMM366

300450126108




AMM367

300450126108




APM350

300450126108




APM351

300450126108



St. Joseph Aspirin Enteric Coated Tablet

AMM323

300450126184



180 ct

AMM433

300450126184




APM304

300450126184


Product Form

Product Name

Lot Number

UPC Code

ST. JOSEPH

 TABLET

St. Joseph Aspirin Enteric Coated Tablet

AHM368

300450126030

ASPIRIN


300 ct

ALM377

300450126030




ALM378

300450126030




AMM354

300450126030




APM427

300450126030

TYLENOL

CAPLET

Tylenol 8 Hour Caplet 24 ct

ACM056

300450297266

8 HOUR



ADM031

300450297266




ADM032

300450297242




AEM087

300450297266




AEM105

300450297266




ALM325

300450297266




AMM322

300450297266




ASM379

300450297266



Tylenol 8 Hour Caplet 100 ct

ACM037

300450297112




AFM351

300450297112




AHM316

300450297112




AHM376

300450297112




AHM422

300450297112




ALM388

300450297112




ALM458

300450297112




AMM368

300450297112




AMM435

300450297112

TYLENOL

CAPLET

Tylenol Arthritis Caplet 50 ct

08KMC123

300450838506

ARTHRITIS



09DMC066

300450838506



Tylenol Arthritis Caplet 150 ct

09GMC101

300450838155




09XMC114

300450838216




09XMC116

300450838216




ASA065

300450838155




ASA304

300450838155



Tylenol Arthritis Caplet 225 ct

07BMC009

300450838377




07EMC027

300450838377




09EMC073

300450838377




09HMC108

300450838377




ASA088

300450838377




ASA119

300450838377




ASA293

300450838377



Tylenol Arthritis Caplet 290 ct

AEA180

300450838292




AHA076

300450838292




AHA077

300450838292


Product Form

Product Name

Lot Number

UPC Code

TYLENOL

CAPLET


AJA019

300450838292

ARTHRITIS



AJA116

300450838292




AJA117

300450838292




ALA029

300450838292




AMA025

300450838292




AMA270

300450838292




APA011

300450838292




APA214

300450838292




APA266

300450838292


GELTAB

Tylenol Arthritis Geltab 20 ct

09BMC031

300450292209



Tylenol Arthritis Geltab 40 ct

08KMC130

300450292407




09BMC024

300450292407



Tylenol Arthritis Geltab 80 ct

ALM345

300450292803




APM305

300450292803




APM419

300450292803




ASM357

300450292803

TYLENOL PM

CAPLET

Extra Strength Tylenol PM Caplet 24 ct

ABA021

300450482242




ABA368

300450482242




AJA025

300450482242




AJA026

300450482242



Extra Strength Tylenol PM Caplet 24+12 ct

AJA027

300450482310



Extra Strength Tylenol PM Caplet 50 ct

AFA005

300450482501




AFA280

300450482501




AFA289

300450482501




AFA357

300450482501



Extra Strength Tylenol PM Caplet 100 ct

AJA174

300450482105




ALA250

300450482105



Extra Strength Tylenol PM Caplet 100+20 ct

ALA251

300450482136



Extra Strength Tylenol PM Caplet 150 ct

SEA188

300450482150



Extra Strength Tylenol PM Caplet 225 ct

ABA415

300450482358




ACA033

300450482358




ACA440

300450482358




ACA441

300450482358




ADA179

300450482358




ADA418

300450482358




AEA073

300450482358




AFA278

300450482358


Product Form

Product Name

Lot Number

UPC Code

 TYLENOL PM

 CAPLET

 Extra Strength Tylenol PM Caplet 225 ct

AFA319

300450482358




AHA067

300450482358




AJA181

300450482358




ALA255

300450482358




AMA053

300450482358




AMA176

300450482358




AMA349

300450482358




APA010

300450482358




APA216

300450482358




SFA084

300450482358




SHA044

300450482358




SHA157

300450482358




SHA230

300450482358




SJA026

300450482358




SLA050

300450482358




SLA272

300450482358




SMA081

300450482358




SSA158

300450482358


GELTAB

Extra Strength Tylenol PM Geltab 24 ct

ABA001

300450176240




ABA370

300450176240




AFA310

300450176240




AHA083

300450176240




AJA051

300450176240



Extra Strength Tylenol PM Geltab 50 ct

AFA177

300450176509




AFA326

300450176509



Extra Strength Tylenol PM Geltab 50+20 ct

AJA098

300450176707


RAPID

Tylenol PM Rapid Release Gelcap  20 ct

ABA002

300450244208


RELEASE


ABA265

300450244208


GELCAP


ADA281

300450244208




AFA327

300450244208



Tylenol PM Rapid Release Gelcap  40 ct

ACA422

300450244406




AEA077

300450244406




AEA258

300450244406




AFA059

300450244406




AFA192

300450244406




AHA172

300450244406









CONSUMER INQUIRIES:

1-888-222-6036 (Mon-Fri 8 a.m. to 10 p.m. EST, and Sat-Sun 9 a.m. to 5 p.m. EST)


MEDIA INQUIRIES:
Marc Boston
215-273-7649 (office)
215-429-7034 (mobile)


Bonnie Jacobs

215-273-8994 (office)
856-912-9965 (mobile)


Teresa Panas

908-904-3198 (office)
973-216-8118 (mobile)


SOURCE McNeil Consumer Healthcare



RELATED LINKS
http://www.mcneilproductrecall.com
http://www.fda.gov/medwatch

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