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Posted by: Kim_Hamilton on 01/16/2010 06:13 AM
Updated by: Kim_Hamilton on 01/16/2010 06:13 AM
Expires: 01/01/2015 12:00 AM
:
McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products
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.
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
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