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Tylenol Recall Expanded
1/15/2010

http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall.inc

 

MCNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF CERTAIN OVER-THE-COUNTER (OTC) PRODUCTS IN THE AMERICAS, UAE, AND FIJI

Fort Washington, PA (January 15, 2010) – 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.

 

 

 

Below you will find more details on specific products that are recalled. To find out if you have a product that is affected, please locate the NDC number and the lot number of the product you have. This information can be found on the box that the product was sold in and on the actual bottle itself. If you need help with finding this information, please call our Consumer Care Center at 1-888-222-6036.

Recall information on certain product lots of TYLENOL® extra strength acetaminophen caplets (325 and 50 count bottles) and TYLENOL® rapid release gels (50 and 24 count bottles)

Product Description:
TYLENOL® EXTRA -STRENGTH 500 MG ACETAMINOPHEN CAPLETS, 325 COUNT

NDC Code #
50580-449-32
UPC #300450444325
LOT #s
SPA005 SPA058
SFA295 09BMC018
09CMC048 09FMC082
09FMC084 AAA405
ADA014 ADA087
ADA270 ADA271
ADA417 AEA348
AFA102 AJA045
ALA028 SFA179
SFA237 SFA295
 
SHA002 SJA025
SJA189 SJA232
 
SLA004 SLA160
SLA296 SMA173
 
SMA174 SPA005
SPA038 SPA386
SSA055  

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 100+25CT

NDC Code #
50580-449-00
UPC #300450449009
LOT #s
SDA203 SHA035

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 100CT

NDC Code #
50580-449-09
UPC #300450449092
LOT #s
AMA008 SSA013
SSA150  

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 150+50CT

NDC Code #
50580-449-46
UPC #300450449467
LOT #s
SFA071  
   

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 150CT

NDC Code #
50580-449-23
UPC #300450449238
LOT #s
AAA419 SEA199
SPA007  

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 225CT

NDC Code #
50580-449-27
UPC #300450444271
LOT #s
SSA011  
   

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 24+12CT

NDC Code #
50580-449-31
UPC #300450444318
LOT #s
ABA565 AHA040
AJA028  

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 24CT

NDC Code #
50580-449-05
UPC #300450449054
LOT #s
AAA408 ABA169
ABA568 ADA192
AHA048 AJA145

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 50+25CT

NDC Code #
50580-449-75
UPC #300450444752
LOT #s
ACA599 ACA755

Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 50CT

NDC Code #
50580-451-50
UPC #300450444752
LOT #s
24862 24881
24901 24970
25994 26054
26213 26305
26356 26377
26515 26541
AEA206 AFA176
AFA325 AHA072
AJA021  

Product Description:
TYLENOL® EXTRA STRENGTH COOL CAPLET 100CT

NDC Code #
 
UPC #300450444103
LOT #s
ALA249  

Product Description:
TYLENOL® EXTRA STRENGTH COOL CAPLET 50CT

NDC Code #
50580-710-50
 
UPC #300450444509
LOT #s
ABA029 ACA563
ADA190 AHA081
AJA095 AJA175

Product Description:
TYLENOL® EXTRA STRENGTH EZ TAB 24CT

NDC Code #
50580-422-24
 
UPC #300450422248
LOT #s
ABA154 ADA193
AFA243 AHA039

Product Description:
TYLENOL® EXTRA STRENGTH EZ TAB 50+25CT

NDC Code #
50580-422-75
 
UPC #3004504227507
LOT #s
ACA562 ACA743
ALA173  

Product Description:
TYLENOL® EXTRA STRENGTH EZ TAB 50CT

NDC Code #
50580-422-50
 
UPC #300450422507
LOT #s
ADA013 AEA259
AHA091 AJA010
AJA123  

Product Description:
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 100+20CT

NDC Code #
50580-488-20
 
UPC #300450488176
LOT #s
ALA253 AMA015

Product Description:
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 150CT

NDC Code #
50580-488-24
UPC #300450488152
LOT #s
ASA015 ABA020
ABA371 ADA280
AHA082 ASA015

Product Description:
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 24CT

NDC Code #
50580-488-29
UPC #300450488213
LOT #s
ABA020 ABA371
ADA280 ADA280
AHA082  

Product Description:
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 290CT

NDC Code #
50580-488-29
UPC #300450488299
LOT #s
SEA191 SEA192
SFA025 SFA026
SFA136 SLA052
SLA198  

Product Description:
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 290CT

NDC Code #
50580-488-29
UPC #300450488213
LOT #s
09AMC008 AAA049
AAA360 ADA022
ADA178 ADA272
ADA482 AEA194
AFA010 AFA292
AHA035 AHA089
AJA167 ALA095
ALA096 SEA191
SEA192 SFA025
SFA026 SFA136
SFA296 SHA039
SHA234 SLA052
SLA198 SLA270
SMA236 SPA037
SPA357 SSA019
SSA030 SSA054
SPA357 SSA019
SSA030 SSA054
SPA037  

Product Description:
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 50CT

NDC Code #
50580-488-50
UPC #300450488503
LOT #s
09AMC008 AEA061
AEA244 AFA103
AFA240 AHA046
AHA080 AJA040
AJA041 ACA451
09AMC008  

Product Description:
TYLENOL® EXTRA STRENGTH TABLET 60CT

NDC Code #
50580-499-68
UPC #300450499684
LOT #s
AEA243  

Product Description:
TYLENOL® REGULAR STRENGTH CAPLET 50CT

NDC Code #
50580-501-50
UPC #350580501504
LOT #s
24777 24900
24971 25971
26019 26133
26271 26422
26482 26521

Product Description:
TYLENOL® REGULAR STRENGTH TABLET 100CT

NDC Code #
50580-496-60
UPC #300450496607
LOT #s
ABA148 ABA266
ABA373 ACA432
AFA101 AHA070
AJA009 ALA099
AMA018  

Product Description:
TYLENOL® 8 HOUR CAPLET 100CT

NDC Code #
50580-297-10
UPC #300450297112
LOT #s
ACM037 AFM351
AHM316 AHM376
AHM422 ALM388
ALM458 AMM368
AMM435  

Product Description:
TYLENOL® 8 HOUR CAPLET 24CT

NDC Code #
50580-297-24
UPC #300450297266
LOT #s
ADM032  
   
   
   

Product Description:
TYLENOL® 8 HOUR CAPLET 24CT

NDC Code #
50580-297-24
UPC #300450297266
LOT #s
ASM379 AMM322
ALM325 AEM105
AEM087 ADM031
ACM056  

Product Description:
TYLENOL® ARTHRITIS CAPLET 150CT

NDC Code #
50580-112-15
 
UPC #300450838155
LOT #s
09GMC101 ASA065
ASA304  

Product Description:
TYLENOL® ARTHRITIS CAPLET 150CT

NDC Code #
50580-112-10
 
UPC #300450838216
LOT #s
09XMC114 09XMC116

Product Description:
TYLENOL® ARTHRITIS CAPLET 225CT

NDC Code #
50580-112-37
 
UPC #300450838377
LOT #s
07BMC009 07EMC027
09EMC073 09HMC108
ASA088 ASA119
ASA293  

Product Description:
TYLENOL® ARTHRITIS CAPLET 290CT

NDC Code #
50580-122-29
 
UPC #300450838292
LOT #s
AEA180 AHA076
AHA077 AJA019
AJA116 AJA117
ALA029 AMA025
AMA270 APA011
APA214 APA266

Product Description:
TYLENOL® ARTHRITIS CAPLET 50CT

NDC Code #
50580-112-50
 
UPC #300450838506
LOT #s
08KMC123 09DMC066

Product Description:
TYLENOL® ARTHRITIS GELTAB 20CT

NDC Code #
50580-292-20
 
UPC #300450292209
LOT #s
09BMC031  

Product Description:
TYLENOL® ARTHRITIS GELTAB 40CT

NDC Code #
50580-292-40
UPC #300450292407
LOT #s
08KMC130 09BMC024

Product Description:
TYLENOL® ARTHRITIS GELTAB 80CT

NDC Code #
50580-292-80
UPC #300450292803
LOT #s
ALM345 APM305
APM419 ASM357

Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 100+20CT

NDC Code #
50580-482-13
UPC #300450482136
LOT #s
ALA251  

Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 100CT

NDC Code #
50580-482-10
UPC #300450482105
LOT #s
AJA174 ALA250

Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 150CT

NDC Code #
50580-482-15
UPC #300450482150
LOT #s
SEA188  

TYLENOL® EXTRA STRENGTH PM CAPLET 225CT

NDC Code #
50580-482-35
UPC #300450482358
LOT #s
ABA415 ACA033
ACA440 ACA441
ADA179 ADA418
AEA073 AFA278
AFA319 AHA067
AJA181 ALA255
AMA053 AMA176
AMA349 APA010
APA216 SFA084
SHA044 SHA157
SHA230 SJA026
SLA050 SLA272
SMA081 SSA158

Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 24+12CT

NDC Code #
50580-482-31
UPC #300450482310
LOT #s
AJA027  

Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 24CT

NDC Code #
50580-482-24
UPC #300450482242
LOT #s
AJA027 ABA021
ABA368 AJA025
AJA026  

Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 50CT

NDC Code #
50580-482-50
UPC #300450482501
LOT #s
AFA005 AFA280
AFA289 AFA357

Product Description:
TYLENOL® EXTRA STRENGTH PM GELTAB 24CT

NDC Code #
50580-176-24
UPC #300450176240
LOT #s
ABA001 ABA370
AFA310 AHA083
AJA051  

Product Description:
TYLENOL® EXTRA STRENGTH PM GELTAB 50+20CT

NDC Code #
50580-176-70
UPC #300450176707
LOT #s
AJA098  

Product Description:
TYLENOL® EXTRA STRENGTH PM GELTAB 50CT

NDC Code #
50580-176-50
UPC #300450176509
LOT #s
AFA177 AFA326

Product Description:
TYLENOL® PM RAPID RELEASE GELCAP 20CT

NDC Code #
50580-244-20
UPC #300450244208
LOT #s
ABA002 ABA265
ADA281 AFA327

Product Description:
TYLENOL® PM RAPID RELEASE GELCAP 40CT

NDC Code #
50580-244-40
UPC #300450244406
LOT #s
ACA422 AEA077
AEA258 AFA059
AFA192 AHA172

RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF CHILDREN’S TYLENOL®

Product Description:
CHILDREN’S TYLENOL® BUBBLEGUM MELTAWAY 30 COUNT

NDC Code #
50580-519-30
UPC # 300450519306
LOT #s
AHA069 SPA022

p> Product Description:
CHILDREN’S TYLENOL® GRAPE MELTAWAY 30 COUNT

NDC Code #
50580-518-30
UPC # 300450518309
LOT #s
AHA023

AHA057