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 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 100CT
 |
NDC Code #
50580-449-09 |
| UPC #300450449092 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 150+50CT
 |
NDC Code #
50580-449-46 |
| UPC #300450449467 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 150CT
 |
NDC Code #
50580-449-23 |
| UPC #300450449238 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 225CT
 |
NDC Code #
50580-449-27 |
| UPC #300450444271 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH CAPLET 24+12CT
 |
NDC Code #
50580-449-31 |
| UPC #300450444318 |
 |
|
|
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 |
 |
|
|
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 |
|
|
|
|
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 |
 |
|
|
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 |
 |
|
|
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 |
 |
|
|
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 |
 |
|
|
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 |
 |
|
|
Product Description:
TYLENOL® ARTHRITIS CAPLET 150CT
 |
NDC Code #
50580-112-10
|
| UPC #300450838216 |
 |
|
|
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 |
 |
|
|
Product Description:
TYLENOL® ARTHRITIS GELTAB 20CT
 |
NDC Code #
50580-292-20
|
| UPC #300450292209 |
 |
|
|
Product Description:
TYLENOL® ARTHRITIS GELTAB 40CT
 |
NDC Code #
50580-292-40 |
| UPC #300450292407 |
 |
|
|
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 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 100CT
 |
NDC Code #
50580-482-10 |
| UPC #300450482105 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH PM CAPLET 150CT
 |
NDC Code #
50580-482-15 |
| UPC #300450482150 |
 |
|
|
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 |
 |
|
|
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 |
 |
|
|
Product Description:
TYLENOL® EXTRA STRENGTH PM GELTAB 50CT
 |
NDC Code #
50580-176-50 |
| UPC #300450176509 |
 |
|
|
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 |
 |
|
|
p> Product Description:
CHILDREN’S TYLENOL® GRAPE MELTAWAY 30 COUNT
 |
NDC Code #
50580-518-30 |
| UPC # 300450518309 |
 |
|
|